Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes

  • STATUS
    Not Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    150
  • sponsor
    M.D. Anderson Cancer Center
Updated on 5 March 2022
cancer
tubal ligation
hysterectomy
absolute neutrophil count
measurable disease
breast cancer
anticoagulants
direct bilirubin
glomerular filtration rate
serum bilirubin
anticoagulant therapy
metastasis
neutrophil count
liver metastasis
tumor cells
liver metastases
biomarker analysis
aptt
solid tumors
solid neoplasm
palb2
talazoparib

Summary

This phase II trial studies how well talazoparib works in treating patients with cancers that have returned after a period of improvement, do not respond to treatment, or have spread to other parts of the body, and have alterations in the breast cancer, early onset (BRCA) genes. Talazoparib may cause tumor cells to die by blocking an enzyme that protects the tumor cells from damage.

Description

PRIMARY OBJECTIVES:

I. To determine whether the PARP inhibitor talazoparib achieves clinical benefit (complete response [CR], partial response [PR] or stable disease [SD] > 24 weeks) in metastatic or inoperable locally advanced or locally recurrent cancer patients who have somatic mutations or deletions of BRCA1 or BRCA2, mutations or homozygous deletions in other BRCA pathway genes, and germline mutations in BRCA1 or BRCA 2 with cancers other than breast or ovarian cancer.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of talazoparib in this patient population. (Across-indication) II. To determine baseline molecular markers (deoxyribonucleic acid [DNA], ribonucleic acid [RNA] and protein) or scores (e.g., microsatellite instability positives, and somatic mutation burden) that may predict clinical benefit. (Within-indication) III. To determine pharmacodynamic (PD) markers in tumor, blood and plasma that may predict outcome. (Within-indication) IV. To determine concordance of BRCA1/2 alterations in archival tissue and pre-treatment biopsies. (Within-indication) V. To determine concordance of genomic alterations in tumor and circulating free DNA. (Within-indication) VI. To evaluate the progression free survival (PFS) in patients. (Within-indication) VII. To evaluate the duration of response (DOR) in patients. (Within-indication) VIII. To evaluate the overall survival (OR) in patients. (Within-indication)

OUTLINE

Patients receive talazoparib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for 1 year.

Details
Condition Advanced Malignant Neoplasm, ATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Metastatic Malignant Neoplasm, PALB2 Gene Mutation, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm
Treatment laboratory biomarker analysis, pharmacological study, Phone Call, Talazoparib, Talazoparib Tosylate
Clinical Study IdentifierNCT02286687
SponsorM.D. Anderson Cancer Center
Last Modified on5 March 2022

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