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Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

NCT01506609 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2021-10-25

Study results available
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Summary

The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

Conditions

Interventions

DRUG

Placebo

DRUG

Veliparib

DRUG

Carboplatin

DRUG

Temozolomide

DRUG

Paclitaxel

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-23
Primary Completion
2018-12-13
Completion
2020-09-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • Israel
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Russia
  • Spain
  • Sweden
  • Ukraine

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 NCT01506609 on ClinicalTrials.gov