Finding studies
Finding studies
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Lead
M.D. Anderson Cancer Center
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
