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    Clinical Trial Results:
    A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients with Previously Undiagnosed Peripheral T-cell Lymphoma Who Have Achieved an Objective Response Following Initial Treatment with CHOP-based Chemotherapy

    Summary
    EudraCT number
    		 2010-022230-81
    Trial protocol
    		 GB   CZ   IE   ES   BE   IT  
    Global end of trial date
    07 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2019
    First version publication date
    09 Aug 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PDX-0170
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01420679
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allos Therapeutics, Inc
    Sponsor organisation address
    11080 Circle Point Road, Suite 200, Westminster, CO, United States, CO80020
    Public contact
    David Stanbury, David Stanbury, +44 (0) 1462424406, clinicaltrials@bionical-emas.com
    Scientific contact
    David Stanbury, David Stanbury, +44 (0) 1462424406, clinicaltrials@bionical-emas.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
    Interim
    Date of interim/final analysis
    13 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Determine the efficacy of pralatrexate compared to observation when administered to patients with previously undiagnosed peripheral T-cell lymphoma (PTCL) who have achieved an objective response after completing at least 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)-based treatment.
    Protection of trial subjects
    Signed and dated informed consent was obtained from enrolled-subjects prior to study participation. All study-related procedures were conducted only after a signed and dated ICF by the subject has been received and is counter-signed by the study investigator.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    06 Jun 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Canada: 2
    Worldwide total number of subjects
    21
    EEA total number of subjects
    12
    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)
    9
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The actual start date of the study was 04 Aug 2011 and the end date was 13 Mar 2015. The study was prematurely terminated. The study was a Phase 3 confirmatory study to demonstrate efficacy of pralatrexate as part of the accelerated approval of Folotyn in the USA.

    Pre-assignment
    Screening details
    		 Eligible subjects were consented and screened against the eligibility criteria and patients randomised in a 2:1 ratio to either pralatrexate or observation.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequential pralatrexate
    Arm description
    		 Patients randomized to the pralatrexate treatment group were to receive pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride [NaCl]) weekly for 3 weeks (± 1 day at each time point) of a 4-week cycle. The initial dose of pralatrexate was 30 mg/m2, which based on protocol-defined criteria, may be reduced to 20 mg/m2 with potential further reductions to 15 and 10 mg/m2. Pralatrexate was continued to be administered until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pralatrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/m2 for 3 weeks of a 4week cycle

    Arm title
    		 Observation
    Arm description
    		 Patients randomized to the Observation group were to remain under observation, attend clinic visits every 4 weeks, and be contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
    Arm type
    		 Standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Sequential pralatrexate Observation
    Started
    14
    7
    Completed
    0
    0
    Not completed
    14
    7
         Patient decision
    1
    -
         AE
    4
    -
         Disease progression
    -
    2
         More than 28 d between doses of pralatrexate
    1
    -
         Investigator decision
    1
    2
         Other reasons
    1
    -
         Sponsor decision
    3
    3
         Development of PD
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Group 1: Pralatrexate was administered via IV push over a minimum of 30 seconds up to a maximum of 5 minutes. One cycle is 4 weeks in duration consisting of weekly dosing at a starting dose of pralatrexate 30 mg/m2 for 3 weeks, followed by 1 week of rest. Dose reduction to 20 mg/m2 with further reductions to 15 and 10 mg/m2 were allowed for defined toxicity. Pralatrexate was administered into a patent free-flowing IV line containing normal saline (0.9% sodium chloride [NaCl]). Group 2: Patients randomized to the Observation group were to remain under observation, attend clinic visits every 4 weeks, and be contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 21 21
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 9 9
        From 65-84 years
    		 12 12
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 13 13

    End points

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    End points reporting groups
    Reporting group title
    Sequential pralatrexate
    Reporting group description
    		 Patients randomized to the pralatrexate treatment group were to receive pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride [NaCl]) weekly for 3 weeks (± 1 day at each time point) of a 4-week cycle. The initial dose of pralatrexate was 30 mg/m2, which based on protocol-defined criteria, may be reduced to 20 mg/m2 with potential further reductions to 15 and 10 mg/m2. Pralatrexate was continued to be administered until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.

    Reporting group title
    Observation
    Reporting group description
    		 Patients randomized to the Observation group were to remain under observation, attend clinic visits every 4 weeks, and be contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.

    Primary: Progression-free survival (PFS) and overall survival (OS)

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    End point title
    		 Progression-free survival (PFS) and overall survival (OS) [1]
    End point description
    No efficacy assessments and analysis was conducted. A full statistical analysis and report were not completed.
    End point type
    Primary
    End point timeframe
    Number of days from randomisation to the date of objective documentation of PD or death, regardless of cause (date of PD or death - date of randomisation +1)
    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: The study was prematurely terminated. No efficacy assessments and analysis was conducted. A full statistical analysis and report were not completed.
    End point values
    		 Sequential pralatrexate Observation
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Number of days
    Notes
    [2] - Study prematurely terminated
    [3] - Study prematurely terminated
    No statistical analyses for this end point

    Secondary: Objective response (complete response [CR] or partial response [PR]) to pralatrexate versus observation

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    End point title
    		 Objective response (complete response [CR] or partial response [PR]) to pralatrexate versus observation
    End point description
    No efficacy assessments and analysis was conducted. A full statistical analysis and report were not completed.
    End point type
    Secondary
    End point timeframe
    Measured from randomisation
    End point values
    		 Sequential pralatrexate Observation
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Disappearance or regression of disease
    Notes
    [4] - Study prematurely terminated
    [5] - Study prematurely terminated
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    04 Aug 2011 and 7 May 2015
    Adverse event reporting additional description
    Safety was evaluated by assessment of physical examinations, clinical laboratory values, treatment-emergent AEs (all grades), SAEs, and discontinuations due to treatment-related AEs. Safety was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale, Version 4.03.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Pralatrexate Treatment Group
    Reporting group description
    		 Patients randomized to the pralatrexate treatment group were to receive pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride [NaCl]) weekly for 3 weeks (± 1 day at each time point) of a 4- week cycle. The initial dose of pralatrexate was 30 mg/m2, which based on protocol-defined criteria, may be reduced to 20 mg/m2 with potential further reductions to 15 and 10 mg/m2. Pralatrexate was continued to be administered until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.

    Reporting group title
    Observation Group
    Reporting group description
    		 Patients randomized to the Observation group were to remain under observation, attend clinic visits every 4 weeks,and be contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.

    Serious adverse events
    		 Pralatrexate Treatment Group Observation Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 14 (28.57%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    3
    1
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Subdural hematoma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nervous system disorders
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIIth nerve paralysis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pralatrexate Treatment Group Observation Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    6 / 7 (85.71%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Varicose vein
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Endodontic procedure
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Stent removal
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Chills
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Face oedema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    6 / 14 (42.86%)
    2 / 7 (28.57%)
         occurrences all number
    10
    2
    Local swelling
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Malaise
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    4 / 14 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    8
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 7 (14.29%)
         occurrences all number
    4
    1
    Mucosal inflammation/Intermittant Mucositis of Mouth
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 14 (35.71%)
    3 / 7 (42.86%)
         occurrences all number
    7
    3
    Dysphonia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    Epistaxis
         subjects affected / exposed
    5 / 14 (35.71%)
    0 / 7 (0.00%)
         occurrences all number
    9
    0
    Hiccups
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Nasal congestion
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    Pleuritic pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    2
    Sneezing
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Hallucination
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Mental status changes
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 7 (0.00%)
         occurrences all number
    7
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Body temperature increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Weight increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Foot fracture
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Skull fracture
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Subdural haematoma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Wound
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Ichthyosis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Carotid artery occlusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Convulsion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Dysaesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 7 (14.29%)
         occurrences all number
    4
    1
    Hypokinesia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Neuropathy peripheral
         subjects affected / exposed
    4 / 14 (28.57%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    Paraesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Viith nerve paralysis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    Thrombocytopenia
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    10
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Ocular hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 7 (14.29%)
         occurrences all number
    10
    1
    Aphthous stomatitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    Diarrhoea
         subjects affected / exposed
    6 / 14 (42.86%)
    1 / 7 (14.29%)
         occurrences all number
    9
    1
    Dry mouth
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Lip ulceration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    6 / 14 (42.86%)
    1 / 7 (14.29%)
         occurrences all number
    12
    1
    Oral dysaesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Stomatitis
         subjects affected / exposed
    5 / 14 (35.71%)
    1 / 7 (14.29%)
         occurrences all number
    16
    1
    Vomiting
         subjects affected / exposed
    4 / 14 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    7
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Blister
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 7 (28.57%)
         occurrences all number
    2
    2
    Eczema
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    1
    2
    Erythema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Macule
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Melanosis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nail disorder
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Night sweats
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Onychoclasis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Penile ulceration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pigmentation disorder
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    4 / 14 (28.57%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    Pruritus generalised
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Rash pruritic
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Skin hyperpigmentation
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Skin ulcer
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Hypotension
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Nocturia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Urinary tract pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 14 (42.86%)
    1 / 7 (14.29%)
         occurrences all number
    7
    1
    Back pain
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Flank pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Pain in extremity
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    Infections and infestations
    Bronchitis viral
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 14 (21.43%)
    2 / 7 (28.57%)
         occurrences all number
    3
    2
    Viral infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Decreased appetite/Anorexia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 May 2011
    Amendment 1: The substantial amendment consists of an amendment to the protocol - protocol v2.0 submitted The patient consent documentation (v2.0) and the EudraCT form (12 May 2011) were updated to reflect the changes made to the protocol. Substantial changes were made to the IMPD. - IMPD v5.3 submitted
    14 Nov 2011
    Amendment 2: Substantial amendment to the IB - Edition 7.0 submitted
    03 Feb 2012
    Amendment 3: Substantial amendment consisting of an amendment to the protocol (v2.1), an update to the IMPD (v5.3) EudraCT form updated to reflect the changes made to the protocol and additional sections populated with data required for EudraCT version 8

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Mar 2015
    The study was prematurely terminated. The study was a Phase 3 confirmatory study to demonstrate efficacy of pralatrexate as part of the accelerated approval of Folotyn in the USA. Spectrum has agreed with FDA to stop the current trial and initiate a new trial with a study design that supports FDA post market requirement.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was prematurely terminated. No efficacy assessments and analysis was conducted. A full statistical analysis and report were not completed.
    For support, Contact us.
    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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