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    Clinical Trial Results:
    A Phase 1/2a, Open-Label, Parallel, Two-Arm, Dose-Escalation Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BAX69 in Subjects with Refractory Ovarian Cancer with Malignant Ascites

    Summary
    EudraCT number
    		 2015-003492-29
    Trial protocol
    		 HU  
    Global end of trial date
    26 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jun 2017
    First version publication date
    08 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    391402
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02540356
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Baxalta Innovations GmbH
    Sponsor organisation address
    Industriestrasse 67, Vienna, Austria, 1221
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Sponsor organisation name
    Baxalta US Inc.
    Sponsor organisation address
    One Baxter Way, Westlake Village, United States, CA 91362
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxalta US Inc., ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxalta US Inc., ClinicalTrialsDisclosure@baxalta.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
    26 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of imalumab (BAX69) and to compare puncture-free survival (PuFS) to puncture-free interval at baseline.
    Protection of trial subjects
    The study was conducted in accordance with the study protocol, the International Conference on Harmonization Guideline for Good Clinical Practice E6 (ICH GCP April 1996), Title 21 of the US Code of Federal Regulations (US CFR), the European Clinical Trial Directive (2001/20/EC and 2005/28/EC), and applicable national and local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    0
    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)
    1
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was stopped early with only 1 subject having been dosed.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 2
    Number of subjects completed
    		 1

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure: 1
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single-Route Arm
    Arm description
    		 Imalumab (BAX69) administered weekly by intraperitoneal (IP) infusion only.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imalumab
    Investigational medicinal product code
    BAX69
    Other name
    BAX69
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    In the Single-Route Arm, Imalumab (BAX69) will be administered intraperitoneal (IP) as 1 of the following predefined dose regimens: 5 mg/kg IP (Cohort S1), 10 mg/kg IP (Cohort S2), 15 mg/kg IP (Cohort S3). IP infusion will be administered at a flowrate of between 6.3 mL/min and 10.0 mL/min.

    Number of subjects in period 1 [1]
    		Single-Route Arm
    Started
    1
    Completed
    0
    Not completed
    1
         terminated from study due to disease progression
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 2 subjects provided informed consent and were screened for study participation. One subject was a screen failure and did not enter the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 Imalumab (BAX69) administered weekly by intraperitoneal (IP) infusion.

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        From 65-84 years
    		 1 1
    Gender categorical
    Units:
        Male
    		 0 0
        Female
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Single-Route Arm
    Reporting group description
    		 Imalumab (BAX69) administered weekly by intraperitoneal (IP) infusion only.

    Primary: The occurrence of dose-limiting toxicity (DLT)

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    End point title
    		 The occurrence of dose-limiting toxicity (DLT) [1]
    End point description
    Study was terminated early with only one subject dosed. No statistical analysis performed. DLT is defined as any drug related treatment-emergent adverse event that occurs during the 28-day period after the first dose of Imalumab and that meets any of these criteria: - Any ≥ grade 3 non-hematologic toxicity assessed by the investigator as related to study drug (except: single lab value out of normal range not necessarily translating or considered a feature of clinical diagnosis requiring an intervention per investigator's interpretation and resolves to ≤ Grade 2 with adequate measure in 7 days; Transient grade 3 elevations of hepatic transaminases in the absence of simultaneous increase in serum bilirubin; Alopecia) - Any toxicity resulted in dose delay for ≥14 days - Any grade 4 hematologic toxicity (except lymphopenia) - Grade 3 febrile neutropenia - Grade 3 thrombocytopenia associated with bleeding - Any life-threatening complication/abnormality not covered in NCICTCAE v4.03
    End point type
    Primary
    End point timeframe
    28 days after the first dose of Imalumab
    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: Due to early study termination no statistical analysis was performed.
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    1
    Units: Subjects
    0
    No statistical analyses for this end point

    Primary: The ratio of puncture free survival (PuFS) over puncture-free interval at baseline

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    End point title
    		 The ratio of puncture free survival (PuFS) over puncture-free interval at baseline [2]
    End point description
    Study was terminated early with only one subject dosed. No statistical analysis was performed. PuFS is defined as the time from the last dose of Imalumab to the first therapeutic paracentesis after that, or death, whichever occurs first. Puncture-free interval at baseline is calculated as the time between the last 2 therapeutic paracenteses immediately before the first dose of Imalubmab.
    End point type
    Primary
    End point timeframe
    Throughout the study period
    Notes
    [2] - 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: Due to early study termination no statistical analysis was performed.
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    0 [3]
    Units: Not available
    Notes
    [3] - No statistical analysis performed for this endpoint due to early study termination.
    No statistical analyses for this end point

    Secondary: The ratio of time to first paracentesis post-treatment over puncture-free interval at baseline

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    End point title
    		 The ratio of time to first paracentesis post-treatment over puncture-free interval at baseline
    End point description
    Study was terminated early with only one subject dosed. No statistical analysis was performed. Time to first paracentesis post-treatment is calculated as the time between the last dose of Imalumab to subsequent first therapeutic paracentesis.
    End point type
    Secondary
    End point timeframe
    Throughout the study period.
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    0 [4]
    Units: Not available
    Notes
    [4] - No statistical analysis performed for this endpoint due to early study termination.
    No statistical analyses for this end point

    Secondary: The change in ascites volume per unit time with treatment

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    End point title
    		 The change in ascites volume per unit time with treatment
    End point description
    Study was terminated early with only one subject dosed. No statistical analysis was performed. The volume of ascites from the last dose of Imalumab to the first post-treatment paracentesis per unit time will be compared to the volume of the last pre-treatment paracentesis per unit time. At each paracentesis, the volume of fluid that can be removed safely (measured by ultrasound-guided paracentesis) to achieve close to dryness should be withdrawn, measured, and documented.
    End point type
    Secondary
    End point timeframe
    Throughout the study period
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    0 [5]
    Units: Not available
    Notes
    [5] - No statistical analysis performed for this endpoint due to early study termination.
    No statistical analyses for this end point

    Secondary: The changes in ascites-related symptoms

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    End point title
    		 The changes in ascites-related symptoms
    End point description
    Study was terminated early with only one subject dosed. No statistical analysis was performed. Ascites related symptoms: anorexia, nausea, early satiety, vomiting, abdominal pain, abdominal swelling, dyspnea, fatigue, swollen ankles, heartburn
    End point type
    Secondary
    End point timeframe
    Baseline, weekly during the treatment period, and every 2 weeks during the safety follow-up period.
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    0 [6]
    Units: Not available
    Notes
    [6] - No statistical analysis performed for this endpoint due to early study termination.
    No statistical analyses for this end point

    Secondary: Occurrence of serious adverse events (SAEs) and/or treatment emergent adverse events (TEAEs), regardless of causality or relationship to study drug

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    End point title
    		 Occurrence of serious adverse events (SAEs) and/or treatment emergent adverse events (TEAEs), regardless of causality or relationship to study drug
    End point description
    Study was terminated early with only one subject dosed. No statistical analysis was performed.
    End point type
    Secondary
    End point timeframe
    Throughout the study period
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    1
    Units: Subjects
        SAEs
    0
        TEAEs related to study drug
    0
        TEAEs not related to study drug
    1
    No statistical analyses for this end point

    Secondary: Occurrence of binding and/or neutralizing anti-BAX69 antibodies following treatment with BAX69

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    End point title
    		 Occurrence of binding and/or neutralizing anti-BAX69 antibodies following treatment with BAX69
    End point description
    Study was terminated early with only one subject dosed. No statistical analysis was performed.
    End point type
    Secondary
    End point timeframe
    Throughout the study period
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    0 [7]
    Units: Not available
    Notes
    [7] - No statistical analysis performed for this endpoint due to early study termination.
    No statistical analyses for this end point

    Secondary: BAX69 plasma pharmacokinetic (PK) parameters

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    End point title
    		 BAX69 plasma pharmacokinetic (PK) parameters
    End point description
    Study was terminated early with only one subject dosed. No statistical analysis was performed. Maximum and minimum observed concentration (Cmax and Cmin), Area under the concentration vs time curve (AUC), half-life (t1/2), apparent systemic clearance (CL/F), volume of distribution (Vz/F)
    End point type
    Secondary
    End point timeframe
    Predose and post-dose at 1.5, 4, 8, 24, and 72 hours
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    0 [8]
    Units: Not available
    Notes
    [8] - No statistical analysis performed for this endpoint due to early study termination.
    No statistical analyses for this end point

    Secondary: Quality of Life (QoL) measure

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    End point title
    		 Quality of Life (QoL) measure
    End point description
    QoL will be assessed using EORTC QLQ-C30. Study was terminated early with only one subject dosed. No statistical analysis was performed.
    End point type
    Secondary
    End point timeframe
    Weekly from the baseline visit to the last week of safety follow-up (8 weeks or longer, if additional treatment will be implemented)
    End point values
    		 Single-Route Arm
    Number of subjects analysed
    0 [9]
    Units: Not available
    Notes
    [9] - No statistical analysis performed for this endpoint due to early study termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of Imalumab until study completion/discontinuation or 56 (± 2 days) following the last dose of Imalumab.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 BAX69 administered weekly by intraperitoneal (IP) infusion only.

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Gastrointestinal disorders
    Abdominal distention (Grade 2)
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Right knee pain (Grade 1)
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypokalemia (Grade 1)
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Hypomagnesemia (Grade 1)
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 May 2015
    Definition of DLT was changed according to FDA recommendation.
    14 Aug 2015
    Revision of inclusion criteria for adequate renal function including estimated glomerular filtration rate >50mL/min/1,73m2. Text added to describe process of preparation and storage of BAX69 for IV and IP infusion. Description of BAX69 administration by IP infusion updated. Multi-gated acquisition scan added. Description of the information to be captured in the Case Report Form for each study drug administration was revised. Clarification regarding events relating to clinical deterioration. New text regarding safety reporting added. Information concerning medical care for AEs during the study added.
    30 Oct 2015
    Clarification of safety assessments in subjects receiving maintenance therapy and in those not receiving maintenance therapy.

    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.
    Study was terminated early with only 1 subject having been dosed in the single-route arm. Therefore no statistical analysis was performed for this study. Only descriptive data for one subject are available.
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