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Clinical Trials/EUCTR2013-002716-28-DE
EUCTR2013-002716-28-DEActive, not recruitingPhase 1

A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of Talazoparib (BMN 673) versus Physician’s Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer, Who Have Received Prior Chemotherapy Regimens for Metastatic Disease

Medivation, Inc., a wholly-owned subsidiary of Pfizer, Inc.0 sites431 target enrollmentStarted: April 11, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
431
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Histologically or cytologically confirmed carcinoma of the breast
  • •Locally advanced breast cancer that is not amendable to curative radiation or surgical cure and/or metastatic desease appropriate for systemic single cytotoxic chemotherapy
  • •Deleterious, suspected deleterious or pathogenic germline BRCA1 or BRCA2 mutation
  • •No more than 3 prior chemotherapy - inclusive regimes for locally advanced and/or metastatic disease
  • •Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant,locally adjuvanced, or metstatic setting
  • •ECOG performance status = 2
  • •Have adequate organ function
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 375
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

  • •Prior treatment with a PARP inhibitor (not included iniparib)
  • •Subjects who add objective disease progression while receiving platinium chemotherapy administereed for locally advanced or metastatic disease.
  • •Subjects who received platinium in the adjuvant or neoadjuvant setting are eligible
  • •CNS metastases except adequately treated brain metastases documented by baseline CT or MRI scan that has not progresses since previous scans and that does not require corticosteroids (except prednisone less than or equal to 5mg/day) for management of CNS symptoms
  • •Prior malignancy except for prior BRCA-associated cancer as long as ther is no current evidence of the prior cancer, carcinmona in situ or non-melanoma skin cancer, and a cancer diagnosed and denitively treated =5 years before randomization with no subsequent evidence of recurrence
  • •Known to be human HIV positive, active hepatitis C virus, or active hepatitis B virus
  • •Known hypersensitivity of any of the components of talazoparib

Investigators

Sponsor
Medivation, Inc., a wholly-owned subsidiary of Pfizer, Inc.

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EUCTR2013-002716-28-BEMedivation, Inc., a wholly-owned subsidiary of Pfizer431