Overview

This trial is active, not recruiting.

Conditions breast neoplasms, brca 1 gene mutation, brca 2 gene mutation
Treatment talazoparib
Phase phase 2
Target PARP
Sponsor Medivation, Inc.
Collaborator Myriad Genetic Laboratories, Inc.
Start date January 2014
End date December 2016
Trial size 140 participants
Trial identifier NCT02034916, 673-201

Summary

The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

- Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or

- Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease
talazoparib

Primary Outcomes

Measure
Determine Objective Response Rate (ORR) for each cohort
time frame: Anticipated in about 24-30 months following first patient enrolled

Secondary Outcomes

Measure
Clinical benefit response (CBR) rate defined as CR + PR + SD lasting ≥ 24 weeks
time frame: Anticipated in about 24-30 months following first patient enrolled
Duration of response (DOR) for objective responders
time frame: Anticipated in about 24-30 months following first patient enrolled
Progression Free Survival (PFS)
time frame: Anticipated in about 24-30 months following first patient enrolled
Overall survival (OS)
time frame: Anticipated in about 24-30 months following first patient enrolled
Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, SAE, AE related to study drug, SAE related to study drug.
time frame: Anticipated in about 24-30 months following first patient enrolled
Pharmacokinetics of talazoparib as assessed by trough plasma concentrations collected on Day 1 of Cycles 2, 3, and 4
time frame: Anticipated in about 24-30 months following first patient enrolled

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed carcinoma of the breast - Locally advanced and/or metastatic disease - Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation - Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease - ECOG performance status ≤ 1 - Have adequate organ function Exclusion Criteria: - Prior enrollment into a clinical trial of a PARP inhibitor - CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids for management of CNS symptoms - Prior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study enrollment with no subsequent evidence of recurrence - Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus - Known hypersensitivity to any of the components of talazoparib

Additional Information

Official title A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673) Administered to Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medivation, Inc..
Location data was received from the National Cancer Institute and was last updated in May 2016.