Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Not Recruiting

Trial ID: NCT02470585


The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel [C/P]) and continued as maintenance therapy compared with chemotherapy alone.

Official Title

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Stanford Investigator(s)

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.

Mary Lake Polan Professor


Inclusion Criteria:

   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 pharmacodynamic 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.

Exclusion Criteria:

   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


drug: Veliparib

drug: Veliparib

drug: Carboplatin

drug: Paclitaxel

other: Placebo to Veliparib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

New Trial Alerts