At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 113 enrolled
Drug / intervention
Talazoparibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Talazoparib for Advanced or Recurrent Solid Tumors and 6 related conditions. Completed, enrolled 113 participants across 15 sites in 2 countries.
Detailed Summary
This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced or Recurrent Solid Tumors, Breast Neoplasms, Ovarian Cancer, Epithelial, Ewing Sarcoma, Small Cell Lung Carcinoma, Prostate Cancer, Pancreas Cancer
CountriesUnited Kingdom, United States
CollaboratorsMedivation, Inc.
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedFeb 2011
Primary CompletionMar 2015
Study CompletionJan 2017
TodayJul 2026
First PostedFeb 1, 2011
Enrollment StartJan 3, 2011
Primary CompletionMar 31, 2015
Study CompletionJan 30, 2017
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.4 years ago
Interventions
Talazoparibdrug
Oral capsule with multiple dosage forms given once daily