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Summary

for females ages 18–99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Keywords

Ovarian Cancer Ovarian Neoplasm Veliparib Carboplatin Paclitaxel Overall Survival ABT-888 Randomized Poly Adenosine Diphosphate (ADP) - Ribose Polymerase (PARP) Ovarian BRCA Ovarian Neoplasms Albumin-Bound Paclitaxel

Eligibility

You can join if…

Open to females ages 18–99

  • 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 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.

You CAN'T join if...

  • 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

Locations

  • Univ California, San Francisco
    San Francisco, California, 94143, United States
  • Kaiser Permanente
    San Francisco, California, 94115, United States
  • Diablo Valley Oncology Hematol
    Pleasant Hill, California, 94523, United States
  • Kaiser Permanente
    Walnut Creek, California, 94596, United States
  • Contra Costa Oncology
    Walnut Creek, California, 94598, United States
  • Cypress Womens Cancer Treatmen
    Walnut Creek, California, 94598, United States
  • John Muir Medical Center
    Concord, California, 94520, United States
  • Stanford Univ School of Med
    Stanford, California, 94305, United States
  • Kaiser Permanente Medical Ctr
    Vallejo, California, 94589-2441, United States
  • Palo Alto Medical Foundation
    Sunnyvale, California, 94086, United States
  • Kaiser Permanente
    Santa Maria, California, 95051, United States
  • UC Davis Comp Cancer Ctr
    Sacramento, California, 95817, United States
  • Renown Regional Medical Center
    Reno, Nevada, 89502, United States
  • Kaiser Permanente
    Los Angeles, California, 90027, United States
  • UCLA
    Los Angeles, California, 90095, United States
  • Long Beach Memorial Medical Ct
    Long Beach, California, 90806, United States
  • Medical Oncology Care Assoc
    Orange, California, 92868-4304, United States
  • Univ CA, Irvine Med Ctr
    Orange, California, 92868, United States
  • Womens Cancer Center of Nevada
    Las Vegas, Nevada, 89169, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02470585
Phase
Phase 3
Study Type
Interventional
Last Updated
January 23, 2018