CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Talazoparib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓HRRD positive by Foundation Medicine Inc. criteria with truncating mutation, frameshift deletion, indel, or missense/nonsense mutation in at least one critical HRR pathway gene (ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCF, FANCM, NBN, PALB2, RAD51, RAD51B, RAD54L, RPA1)
  • ✓Achieved stable disease, partial response, or complete response at first disease assessment after initiation of first-line platinum-based chemotherapy
  • ✓Able to take oral medications and swallow capsules whole without crushing or altering them
  • ✓Must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400 master protocol
Key exclusion· 5
  • ✕Prior exposure to any PARP inhibitor (veliparib, olaparib, rucaparib, niraparib, talazoparib)
  • ✕Progression at first disease assessment after initiation of first-line platinum-based chemotherapy
  • ✕Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter absorption of talazoparib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, active peptic ulcer disease)
  • ✕Active small or large intestine inflammation such as Crohn's disease or ulcerative colitis within 12 months of sub-study registration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03377556
NCT03377556Phase 2Completed
CompareCT.gov

A Phase II Study of Talazoparib (BMN 673) in Patients With Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

SWOG Cancer Research Network·interventional·Posted Dec 19, 2017·Updated Jun 23, 2021

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Pharmacological Study, and 1 other intervention for ATM Gene Mutation and 20 related conditions. Completed, enrolled 51 participants across 1,157 sites in 2 countries.

Detailed Summary

This phase II trial studies how well talazoparib works in treating patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer that has come back after previous treatment. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsATM Gene Mutation, ATR Gene Mutation, BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, CHEK1 Gene Mutation, CHEK2 Gene Mutation, FANCA Gene Mutation, FANCC Gene Mutation, FANCD2 Gene Mutation, FANCF Gene Mutation, FANCM Gene Mutation, NBN Gene Mutation, PALB2 Gene Mutation, RAD51 Gene Mutation, RAD51B Gene Mutation, RAD54L Gene Mutation, Recurrent Squamous Cell Lung Carcinoma, RPA1 Gene Mutation, Stage IV Squamous Cell Lung Carcinoma AJCC v7
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 19, 2017
Enrollment StartMar 3, 2017
Primary CompletionJan 10, 2021
Study CompletionApr 16, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.5 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Talazoparibdrug

Given PO