Overview

This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments veliparib, temozolomide, carboplatin, paclitaxel, placebo
Phase phase 2
Targets BRCA, PARP
Sponsor AbbVie (prior sponsor, Abbott)
Start date January 2012
End date May 2017
Trial size 290 participants
Trial identifier NCT01506609, 2011-002913-12, M12-895

Summary

The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Veliparib on Day 1 thru 7 and temozolomide on Day 1 thru 5 of a 28-day cycle.
veliparib ABT-888
Days 1 through 7 of 28-day cycle (in combination with Temozolomide) or Days 1 through 7 of 21-day cycle (in combination with Carboplatin and Paclitaxel).
temozolomide Temodal
Days 1 through 5 of 28-day cycle (in combination with veliparib).
(Experimental)
Veliparib on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
veliparib ABT-888
Days 1 through 7 of 28-day cycle (in combination with Temozolomide) or Days 1 through 7 of 21-day cycle (in combination with Carboplatin and Paclitaxel).
carboplatin
Day 3 of 21-day cycle
paclitaxel Taxol
Day 3 of 21-day cycle.
(Placebo Comparator)
Placebo on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
carboplatin
Day 3 of 21-day cycle
paclitaxel Taxol
Day 3 of 21-day cycle.
placebo
Placebo comparator for Veliparib days 1 through 7 of 21-day cycle (in combination with carboplatin and/or paclitaxel).

Primary Outcomes

Measure
Progression -Free Survival
time frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle

Secondary Outcomes

Measure
Overall Survival
time frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation
Clinical Benefit Rate (CBR)
time frame: From Cycle 1 Day1 until patient's death or 3 years post discontinuation
Objective Response Rate
time frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic. - Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent. - Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation. - If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy. - Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1. - Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. - Subject must have adequate bone marrow, renal and hepatic function. - Subject must not be pregnant or plan to conceive a child. Exclusion Criteria: - Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1 - More than 2 prior lines of cytotoxic chemotherapy - Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor. - Prior taxane therapy for metastatic breast cancer. - A history of or evidence of brain metastases or leptomeningeal disease. - A history of uncontrolled seizure disorder - Pre-existing neuropathy from any cause in excess of Grade 1 - Known history of allergic reaction to cremophor/paclitaxel - Clinical significant uncontrolled conditions â€" active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance. - Pregnant or breastfeeding

Additional Information

Official title A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Description Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups. The safety of each treatment group will be assessed by evaluating study drug exposure, adverse events, serious adverse events, all deaths, changes in laboratory determinations, and vital sign parameters. The Clinical Benefit Rate (CBR) and Objective Response Rate (ORR) as well as Progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be assessed. Study visits will be conducted according to the protocol schedule and randomization group. Study visits will include physical examination, laboratory blood sample collection, and assessment of vital signs, medical history and urinalysis. 12-lead Electrocardiogram (ECG) will be performed at protocol specified visits.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.