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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

Trial Status: Closed to Accrual

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.

Inclusion Criteria

  • 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.
  • High-grade serous adenocarcinoma
  • Willing to undergo testing for gBRCA.
  • Adequate hematologic, renal, and hepatic function.
  • Neuropathy (sensory and motor) less than or equal to Grade 1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • 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.
  • Participants with measurable disease or non-measurable disease are eligible. Participants may or may not have cancer-related symptoms.
  • 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

  • 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.
  • 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.
  • 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.
  • Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
  • Received prior chemotherapy for any abdominal or pelvic tumor.
  • Clinically significant uncontrolled condition(s).
  • 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.
  • 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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL

Arizona

Phoenix
Cancer Center at Saint Joseph's
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: John Hall Farley
Phone: 877-602-4111
Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Mitzi Lee Miranda
Phone: 520-626-0950

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Krishnansu Sujata Tewari
Phone: 877-827-8839
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
San Diego
University of California San Diego
Status: ACTIVE
Contact: Michael T. McHale
Phone: 858-822-5354
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: Jasmine L Bernal
Phone: 415-885-7206

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL

Connecticut

New Haven
Yale University
Status: ACTIVE
Contact: Elena S. Ratner
Phone: 203-785-5702

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL

Hawaii

Honolulu
University of Hawaii Cancer Center
Status: ACTIVE
Contact: Michael Ethan Carney
Phone: 808-983-6090

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Sherry Beeler
Phone: 317-278-5627

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: David Paul Bender
Phone: 800-237-1225

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Julia Ann Chapman
Phone: 913-945-7552
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Contact: Frederick Rand Ueland
Phone: 859-257-3379

Maryland

Baltimore
MedStar Franklin Square Medical Center / Weinberg Cancer Institute
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Jamie Nadine Bakkum-Gamez
Phone: 507-538-7623

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL
Contact: David Gardner Mutch
Phone: 800-600-3606

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Sarah F. Adams
Phone: 505-925-0366

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
New York
Icahn School of Medicine at Mount Sinai
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Linda Van Le
Phone: 877-668-0683
Durham
Duke University Medical Center
Status: ACTIVE
Contact: Angeles Alvarez Secord
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: SCC Clinical Trials Office
Phone: 405-271-8777

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Thomas Jefferson University Hospital
Status: CLOSED_TO_ACCRUAL
University of Pennsylvania / Abramson Cancer Center
Status: CLOSED_TO_ACCRUAL
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL
Contact: Alexander Babatunde Olawaiye
Phone: 412-647-2811

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Theresa Louise Werner
Phone: 801-581-4477

Virginia

Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Participants were randomized in a 1:1:1 ratio to one of three arms. Randomization in the entire population was stratified according to the timing of surgery and residual disease status (any residual disease after primary surgery vs. no residual disease after primary surgery vs. interval surgery) and the paclitaxel schedule (weekly vs. every 3 -weeks), stage of disease (III vs. IV), geographic region (Japan vs. North America and rest of world [ROW]), and germline breast cancer susceptibility gene (BRCA) mutation status (positive versus negative or Unknown). Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval). The weekly or every-3-week paclitaxel schedule and the choice of primary or interval cytoreductive surgery were determined at the discretion of the investigator. The primary objective was evaluated in the BRCA-deficient cohort, participants with homologous recombination deficiency (HRD), and the intention-to-treat (ITT) population. These populations were sequentially inclusive, with the HRD population including the BRCA-deficient population, and the ITT population including the HRD and BRCA-deficient populations. The BRCA-deficient population was defined as participants with either a germline (gBRCA) and/or tissue-based (tBRCA) deleterious or suspected deleterious mutation in BRCA1 or BRCA2 confirmed by centralized testing. The HRD population was defined as participants with HRD tumors based on HRD score or presence of a deleterious or suspected deleterious mutation in BRCA1 or BRCA2 as determined by centralized testing.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Abbvie

  • Primary ID M13-694
  • Secondary IDs NCI-2015-01623, 2014‐005070‐11, 2014-005070-11
  • Clinicaltrials.gov ID NCT02470585