Veliparib in combination with carboplatin and paclitaxel and as continuation maintenance therapy in subjects with newly diagnosed, untreated Stage III or IV high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Conditions
- ewly diagnosed, untreated Stage III or IV high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005070-11-PL
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1100
Subject must be = 18 years of age
High-grade serous adenocarcinoma
Willing to undergo testing for gBRCA
Eastern Cooperative Oncology Group performance status of 0, 1, or 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 990
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 110
Following histologic cell types are ineligible: endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
Synchronous primary endometrial cancer, or a past history of endometrial cancer.
Prior radiotherapy to any portion of the abdominal cavity or pelvis
Clinically significant uncontrolled condition(s), including but not limited to: Bowel obstruction or gastric outlet obstruction.
History or evidence upon physical examination of central nervous system (CNS) disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate whether progression-free survival (PFS) is prolonged when veliparib is added to standard platinum-based chemotherapy and then continued as maintenance in the BRCA-deficient, HRD and whole populations.;Secondary Objective: Secondary objectives include evaluations of overall survival, safety and Disease Related Symptom scores in the BRCA-deficient, HRD and whole populations.;Primary end point(s): Progression free survival in the BRCA-deficient, HRD and whole populations.;Timepoint(s) of evaluation of this end point: PFS will be defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression, according to RECIST criteria version 1.1 (as determined by the Investigator) or to the date of death (all causes of mortality) if disease progression is not reached.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: OS timepoint evaluation:<br>OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death. <br><br>DRS Scores:<br>The overall mean change from baseline for the DRS scores will be measured at each assessment point up to 2 years or disease progression. <br><br>Safety:<br>The safety of veliparib will be assessed by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters. Subjects who were randomized but did not receive study drug will not be included in the analyses of safety.;Secondary end point(s): The secondary efficacy analyses for OS will be measured in the BRCA-deficient, HRD and whole populations. PFS will also be compared as a secondary analysis. Other secondary analyses will include safety and Disease Related Symptom (DRS) scores in the BRCA-deficient, HRD and whole populations.