BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01624493|
Recruitment Status : Withdrawn (Phase I was conducted Australia. Phase II not conducted and no US pts enrolled.)
First Posted : June 20, 2012
Last Update Posted : December 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Carboplatin Drug: Gemcitabine Drug: BNC105P||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients in First or Second Relapse|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Phase II Arm A
Phase II Arm A will randomize patients to treatment regimen of carboplatin and gemcitabine without BNC105P
Carboplatin AUC4 on day 1 of 21-day cycle, for a maximum of 6 cycles.
Gemcitabine escalations 800 and 1000 mg/m2 (as determined in phase I) on days 1 and 8 of a 21 day cycle, for a maximum of 6 cycles.
Experimental: Phase II Arm B
Phase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P
Carboplatin AUC 4 on day 1 of a 21 day cycle, for a maximum of 6 cycles.
Gemcitabine 800 or 1000 mg/m2 (as determined in phase I) on days 1 and day 8 of 21-day cycle, for a maximum of 6 cycles.
BNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles.
- Phase I: Determine Maximum Tolerated Dose for Patients [ Time Frame: 12 months ]To determine the recommended dose of BNC105P given with gemcitabine and carboplatin (maximum dose of BNC105P with no more than 1 DLT in 6 phase I participants)
- Phase II: Determine Objective Response Rate in Patients [ Time Frame: 12 months ]To determine the objective response rate (ORR) in those with evaluable disease (ORR = CR, PR according to RECIST 1.1 and/or GCIG CA125 criteria) (percentage of those with measurable disease achieving CR or PR according to RECIST 1.1 and/or GCIG CA125 criteria)
- Progression Free and Overall Survival Distribution [ Time Frame: 12 months ]To determine the progression free and overall survival distribution rates in this patient population
- Patient Side Effects and Tolerability [ Time Frame: 12 months ]To determine the adverse event rates (Numbers (%) with G2-5 AE (NCI CTCAE v4.0)
- Patient Quality of Life Benefits [ Time Frame: 12 months ]To determine the effects on aspects of health related quality of life (HRQL measured with FOSI and MOST), including symptom benefit (Numbers (%) with significant symptom benefit)
- Assessment of BNC105P Pharmacokinetics to Determine Interaction with Carboplatin and Gemcitabine [ Time Frame: 12 months ]Plasma will be collected to assess BNC105P pharmacokinetics on days 2 and 9 of cycle 1 only. Results will be compared with data from previous trials of BNC105P to determine their consistency and to establish if there is any major interaction with carboplatin and gemcitabine.
- Association of Biomarkers, Predictions and Outcomes [ Time Frame: 12 months ]To determine the associations between baseline biomarkers, ORR, PFS, OS and AE
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624493
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Australia, New South Wales|
|Royal Prince Alfred Hospital|
|Sydney, New South Wales, Australia, 2050|
|Royal Brisbane and Women's Hospital|
|Brisbane, Queensland, Australia, 4029|
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 8006|
|Christchurch, Canterbury, New Zealand, 4710|
|Study Chair:||Danny Rischin, Professor||University of Sydney|
|Principal Investigator:||Daniela Matei, M.D.||Hoosier Cancer Research Network|