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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

NCT02470585 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1140

Last updated 2024-10-26

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Veliparib

Capsules for oral administration

DRUG

Paclitaxel

Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).

DRUG

Carboplatin

Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.

OTHER

Placebo to Veliparib

Capsules for oral administration

Sponsors & Collaborators

  • Australia New Zealand Gynaecological Oncology Group

    collaborator OTHER

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-14
Primary Completion
2019-05-03
Completion
2023-10-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Denmark
  • Israel
  • Japan
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470585 on ClinicalTrials.gov