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
- Not 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
- Secondary Outcome Measures
Name Time Method