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    Clinical Trial Results:
    A Phase 2 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in the Treatment of Patients with Platinum-Refractory or Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

    Summary
    EudraCT number
    		 2008-006979-72
    Trial protocol
    		 FR   PL  
    Global end of trial date
    27 Jan 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2018
    First version publication date
    30 Dec 2016
    Other versions
    Summary report(s)
    		 Summary Results

    Trial information

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    Trial identification
    Sponsor protocol code
    C14006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00853307
    WHO universal trial number (UTN)
    		 U1111-1187-6616
    Sponsors
    Sponsor organisation name
    Takeda Oncology
    Sponsor organisation address
    40 Landsdowne Street, Cambridge, MA, United States, 02139
    Public contact
    Medical Director, Clinical Science, Takeda Oncology, +1 844-662-8532, GlobalOncologyMedinfo@takeda.com
    Scientific contact
    Medical Director, Clinical Science, Takeda Oncology, +1 844-662-8532, GlobalOncologyMedinfo@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jan 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to estimate the objective antitumor response rate of alisertib using the Response Evaluation Criteria in Solid Tumors (RECIST criteria) or CA 125 criteria(1) in participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Mar 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    United States: 23
    Worldwide total number of subjects
    31
    EEA total number of subjects
    8
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    21
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 17 investigative sites in France, Poland and the United States from 23 March 2009 to 27 January 2011.

    Pre-assignment
    Screening details
    		 Participants with a diagnosis of Platinum-refractory and Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma received 50 mg alisertib twice daily for 7 days in 21-day cycles.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Alisertib 50 mg (Platinum-Refractory)
    Arm description
    		 Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alisertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with Platinum-Refractory received Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).

    Arm title
    		 Alisertib 50 mg (Platinum-Resistant)
    Arm description
    		 Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alisertib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with Platinum-Resistant received Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).

    Number of subjects in period 1
    		Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Started
    6
    25
    Completed
    4
    20
    Not completed
    2
    5
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    2
         Reason Not Specified
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Alisertib 50 mg (Platinum-Refractory)
    Reporting group description
    		 Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.

    Reporting group title
    Alisertib 50 mg (Platinum-Resistant)
    Reporting group description
    		 Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.

    Reporting group values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant) Total
    Number of subjects
    		 6 25 31
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 25 31
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.3 ( 15.38 ) 56.6 ( 14.19 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 6 25 31
        Male
    		 0 0 0
    Primary diagnosis
    Units: Subjects
        Epithelial Ovarian
    		 5 20 25
        Fallopian Tube
    		 0 1 1
        Primary Peritoneal Carcinoma
    		 1 4 5
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    ECOG performance is defined as: 0=Normal activity (fully active, able to carry on all predisease performance without restriction); 1=Symptoms but ambulatory (restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature); 2=In bed <50% of the time (ambulatory and capable of all self-care, but unable to carry out any work activities); 3=In bed >50% of the time (capable of only limited self-care); 4=100% bedridden (completely disabled, cannot carry on any selfcare, totally confined to bed or chair).
    Units: Subjects
        ECOG Performance Status = 0
    		 2 18 20
        ECOG Performance Status = 1
    		 4 7 11
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 6 24 30
        Asian
    		 0 1 1
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 1 1 2
        Not Hispanic or Latino
    		 3 22 25
        Not Reported
    		 2 2 4
    Study Specific Characteristic | Years Since Initial Diagnosis
    Units: years
        arithmetic mean (standard deviation)
    		 1.59 ( 0.736 ) 2.26 ( 1.448 ) -
    Study Specific Characteristic | Height
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    		 162.0 ( 4.83 ) 160.9 ( 7.76 ) -
    Study Specific Characteristic | Weight
    Units: kilogram (kg)
        arithmetic mean (standard deviation)
    		 65.16 ( 9.638 ) 68.22 ( 17.227 ) -
    Study Specific Characteristic | Body Surface Area (BSA)
    Body Surface Area = square root [height (cm)*weight (kg) / 3600 ].
    Units: meter (m)^2
        arithmetic mean (standard deviation)
    		 1.72 ( 0.167 ) 1.72 ( 0.223 ) -

    End points

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    End points reporting groups
    Reporting group title
    Alisertib 50 mg (Platinum-Refractory)
    Reporting group description
    		 Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.

    Reporting group title
    Alisertib 50 mg (Platinum-Resistant)
    Reporting group description
    		 Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.

    Primary: Combined Best Overall Response Rate (ORR) Based on Investigator Assessment

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    End point title
    		 Combined Best Overall Response Rate (ORR) Based on Investigator Assessment [1]
    End point description
    Combined ORR:percentage of participants with Complete Response(CR)+Partial Response(PR) as assessed by the investigator according to RECIST criteria 1.1 or response by Cancer antigen(CA) 125 criteria.According to RECIST,CR:disappearance of all target lesions;PR:30% decrease in the sum of the longest diameter of target lesions.CA 125 response criteria is defined as either:50% decrease from 2 initially elevated samples;sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later(a total of 4 samples required)or serial decrease of >75% over 3 samples;the third sample was to be obtained 28 days after the second (a total of 3 samples required).Response-evaluable population:all participants who have measurable neoplastic disease according to RECIST criteria OR participants with CA 125 level >40 units/milliliter(mL) and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment.
    End point type
    Primary
    End point timeframe
    Every 2 cycles up to 12 months until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU)-every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses are reported for this endpoint.
    End point values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Number of subjects analysed
    6
    25
    Units: percentage of participants
    0
    12
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS is defined as the time in days from the date of first study drug administration to the date of first documented Progressive Disease (PD) or death. PD is defined as 20% increase in the sum of the longest diameter of target lesions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. For a participant who has not progressed and has not died, PFS is censored at the last response assessment that is stable disease (SD) or better. Response-evaluable population is defined as all participants who have measurable neoplastic disease according to RECIST criteria OR participants with CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment.
    End point type
    Secondary
    End point timeframe
    Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
    End point values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Number of subjects analysed
    6
    25
    Units: days
        median (confidence interval 95%)
    36.5 (23.0 to 120.0)
    77.0 (43.0 to 122.0)
    No statistical analyses for this end point

    Secondary: Duration Of Response (DOR)

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    End point title
    		 Duration Of Response (DOR)
    End point description
    DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions. Enrollment was closed after 31 participants were enrolled based on interim analysis results, which did not show the level of response needed to justify further investigation.
    End point type
    Secondary
    End point timeframe
    Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
    End point values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: days
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [2] - As there were only 3 responders, DOR was not analyzed.
    [3] - As there were only 3 responders, DOR was not analyzed.
    No statistical analyses for this end point

    Secondary: Time To Progression (TTP)

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    End point title
    		 Time To Progression (TTP)
    End point description
    TTP is defined as the time in days from the date of first study drug administration to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions. Enrollment was closed after 31 participants were enrolled based on interim analysis results, which did not show the level of response needed to justify further investigation.
    End point type
    Secondary
    End point timeframe
    Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
    End point values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: days
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [4] - Enrollment was closed after 31 participants. TTP was not analyzed.
    [5] - Enrollment was closed after 31 participants. TTP was not analyzed.
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate

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    End point title
    		 Clinical Benefit Rate
    End point description
    Clinical benefit rate is defined as the percentage of participants with response and stable disease (SD), where in order for SD to qualify as having clinical benefit, there must be no progression of neoplastic disease for at least 4 treatment cycles. Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and receive at least 1 dose of alisertib and have at least 1 post-baseline response assessment.
    End point type
    Secondary
    End point timeframe
    Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
    End point values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Number of subjects analysed
    6
    25
    Units: percentage of participants
    0
    32
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events

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    End point title
    		 Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Safety Population is defined as all participants who received any amount of alisertib.
    End point type
    Secondary
    End point timeframe
    First dose to 30 days past last dose (Up to 18.9 Months)
    End point values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Number of subjects analysed
    6
    25
    Units: participants
        AE
    6
    24
        SAE
    4
    7
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Vital Signs reported as Treatment-Emergent Adverse Events

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    End point title
    		 Number of Participants with Abnormal Vital Signs reported as Treatment-Emergent Adverse Events
    End point description
    Vital signs included blood pressure, pulse rate, and oral temperature collected throughout the study. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug. Safety Population is defined as all participants who received any amount of alisertib.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 1 Days 8 and 15, then Day 1 of every cycle (21 days), End of Treatment, End of Study/FU every 12 weeks for up to 12 months (Up to 22 Months)
    End point values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Number of subjects analysed
    6
    25
    Units: participants
        Pyrexia
    2
    6
        Dyspnoea
    0
    4
        Weight decreased
    0
    3
        Tachycardia
    0
    2
        Hypertension
    0
    2
        Dyspnoea exertional
    0
    1
        Bradycardia
    0
    1
        Shock
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Laboratory Values reported as Treatment-Emergent Adverse Events

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    End point title
    		 Number of Participants with Abnormal Laboratory Values reported as Treatment-Emergent Adverse Events
    End point description
    Laboratory tests included Hematology and Chemistry. Abnormal laboratory value were assessed as an AE if the value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Safety Population is defined as all participants who received any amount of alisertib.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 1 Days 8 and 15, then Every cycle Days 1, 8 and 15 to End of Treatment Up to 18.0 Months
    End point values
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Number of subjects analysed
    6
    25
    Units: participants
        Neutropenia
    3
    17
        Anaemia
    2
    14
        Leukopenia
    1
    11
        Thrombocytopenia
    1
    8
        Dehydration
    1
    7
        Hypokalaemia
    2
    4
        Alanine aminotransferase increased
    0
    6
        Aspartate aminotransferase increased
    0
    6
        Hyperglycaemia
    1
    4
        Hypomagnesaemia
    1
    4
        Blood alkaline phosphatase increased
    1
    4
        Febrile neutropenia
    0
    3
        Hyponatraemia
    1
    2
        Haemoglobin decreased
    1
    2
        Granulocytopenia
    0
    2
        Neutrophil count increased
    0
    2
        White blood cell count increased
    0
    2
        Hyperbilirubinaemia
    1
    1
        Lymphopenia
    1
    0
        Hyperkalaemia
    0
    1
        Hypernatraemia
    0
    1
        Hypercholesterolaemia
    0
    1
        Transaminases increased
    1
    0
        Granulocyte count decreased
    0
    1
        Blood calcium increased
    0
    1
        Blood magnesium decreased
    0
    1
        Platelet count decreased
    1
    0
        Blood albumin decreased
    0
    1
        Creatinine renal clearance decreased
    0
    1
        Hypoxia
    0
    1
        Bacteraemia
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose of study drug to 30 past last dose of study drug (Up to18.9 Months)
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.1
    Reporting groups
    Reporting group title
    Alisertib 50 mg (Platinum-Refractory)
    Reporting group description
    		 Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.

    Reporting group title
    Alisertib 50 mg (Platinum-Resistant)
    Reporting group description
    		 Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.

    Serious adverse events
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    7 / 25 (28.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Shock
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 25 (12.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium colitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    24 / 25 (96.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 6 (50.00%)
    15 / 25 (60.00%)
         occurrences all number
    5
    25
    Pyrexia
         subjects affected / exposed
    1 / 6 (16.67%)
    5 / 25 (20.00%)
         occurrences all number
    1
    5
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    0
    4
    Chills
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    0
    4
    Early satiety
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    4
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    10
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    4
    Rhinitis allergic
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    4
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Insomnia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    6 / 25 (24.00%)
         occurrences all number
    0
    9
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    6 / 25 (24.00%)
         occurrences all number
    0
    9
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 25 (16.00%)
         occurrences all number
    2
    24
    Haemoglobin decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    1
    13
    Weight decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    0
    4
    Neutrophil count increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    5
    White blood cell count increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    5
    Platelet count decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    5 / 25 (20.00%)
         occurrences all number
    1
    12
    Somnolence
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    6
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Dysgeusia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Depressed level of consciousness
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    3 / 6 (50.00%)
    16 / 25 (64.00%)
         occurrences all number
    5
    58
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    13 / 25 (52.00%)
         occurrences all number
    1
    24
    Leukopenia
         subjects affected / exposed
    1 / 6 (16.67%)
    11 / 25 (44.00%)
         occurrences all number
    1
    51
    Thrombocytopenia
         subjects affected / exposed
    1 / 6 (16.67%)
    7 / 25 (28.00%)
         occurrences all number
    2
    17
    Granulocytopenia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    9
    Lymphopenia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 6 (50.00%)
    14 / 25 (56.00%)
         occurrences all number
    3
    37
    Stomatitis
         subjects affected / exposed
    2 / 6 (33.33%)
    13 / 25 (52.00%)
         occurrences all number
    2
    19
    Nausea
         subjects affected / exposed
    3 / 6 (50.00%)
    11 / 25 (44.00%)
         occurrences all number
    5
    15
    Vomiting
         subjects affected / exposed
    4 / 6 (66.67%)
    8 / 25 (32.00%)
         occurrences all number
    5
    11
    Abdominal pain
         subjects affected / exposed
    2 / 6 (33.33%)
    8 / 25 (32.00%)
         occurrences all number
    2
    9
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 25 (16.00%)
         occurrences all number
    1
    7
    Ascites
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    Flatulence
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Abdominal distension
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    4
    Abdominal pain upper
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    3
    Dysphagia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Gingival bleeding
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Abdominal rigidity
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 6 (16.67%)
    14 / 25 (56.00%)
         occurrences all number
    1
    18
    Dry skin
         subjects affected / exposed
    0 / 6 (0.00%)
    5 / 25 (20.00%)
         occurrences all number
    0
    5
    Pruritus
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    4
    Rash pruritic
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    5
    Erythema
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    Hyperhidrosis
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    4
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Bladder spasm
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Renal failure acute
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Ureteric obstruction
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 25 (12.00%)
         occurrences all number
    1
    4
    Arthralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    6
    Bone pain
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Shoulder pain
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 25 (12.00%)
         occurrences all number
    1
    4
    Sinusitis
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 6 (0.00%)
    7 / 25 (28.00%)
         occurrences all number
    0
    7
    Dehydration
         subjects affected / exposed
    1 / 6 (16.67%)
    6 / 25 (24.00%)
         occurrences all number
    2
    15
    Hyperglycaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 25 (16.00%)
         occurrences all number
    1
    11
    Hypokalaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 25 (16.00%)
         occurrences all number
    1
    5
    Hypomagnesaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 25 (16.00%)
         occurrences all number
    1
    8
    Hyponatraemia
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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