NCT02470585

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,140 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ovarian Cancer
• Ovarian Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-14
• Primary completion: 2019-05-03
• Completion: 2023-10-05
• First posted: 2015-06-12
• Last updated: 2024-10-26
• Results posted: 2020-09-14

Locations

210 sites across 11 countries: United States, Australia, Brazil, Denmark, Israel, Japan, New Zealand, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study