The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib
in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian,
fallopian tube, or primary peritoneal cancer.
1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO)
Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma,
with the appropriate tissue available for histologic evaluation.
2. High-grade serous adenocarcinoma
3. Willing to undergo testing for gBRCA.
4. Adequate hematologic, renal, and hepatic function.
5. Neuropathy (sensory and motor) less than or equal to Grade 1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
7. Participants who undergo primary cytoreductive surgery must be entered between 1 and
12 weeks after surgery. Participants undergoing interval surgery must have a tumor
sample confirming the histological diagnosis prior to enrollment.
8. Participants with measurable disease or non-measurable disease are eligible.
Participants may or may not have cancer-related symptoms.
9. Participant has one of the following available for PD analyses including somatic BRCA
testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or
tumor tissue biopsy collected prior to Cycle 1 Day 1.
1. 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.
2. Participants with synchronous primary endometrial cancer, or a past history of
endometrial cancer unless all of the following conditions are met: endometrial cancer
stage not greater than IA, no vascular or lymphatic invasion, no poorly
differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions.
3. Participants with any evidence of other invasive malignancy being present within the
last 3 years (with the exception of non-melanoma skin cancer). Participants are also
excluded if their previous cancer treatment contraindicates this protocol's therapy.
4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
5. Received prior chemotherapy for any abdominal or pelvic tumor.
6. Clinically significant uncontrolled condition(s).
7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin,
Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange
Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any
study supplied drug.
8. History or evidence upon physical examination of central nervous system (CNS)
disease, including primary brain tumor, any brain metastases, or history of
cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6
months of Cycle 1 Day 1.