Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and … (NCT02286687) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes
United States150 participantsStarted 2014-12-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with advanced or metastatic cancer that is refractory to standard therapy or has relapsed after standard therapy
* Patients must have one of the following: somatic mutations or deletions in BRCA1 or BRCA2; genomic alterations in other BRCA pathway genes (subcohorts: a. ATM, b. PALB2, c. other genes, e.g. Fanconi Anemia genes, ARID1A, MER11, RAD50, NBS1, ATR; amplification of EMSY); or germline mutation in BRCA1 or BRCA 2 (not breast or ovarian cancer)
* Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Absolute neutrophil count \>= 1500/mL
* Platelets \>= 100,000/mL
* Hemoglobin \>= 9 g/dL (or \>= 5.6 mmol/L)
* Serum creatinine =\< 1.5 x upper limit of normal (ULN) (or glomerular filtration rate \[GFR\] \>= 60 ml/min for patients with creatinine \> 1.5 x ULN)
* Serum total bilirubin =\< 1.5 x ULN (direct bilirubin =\< ULN if total bilirubin \[bili\] \> 1.5 x ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN (or =\< 5 x ULN if liver metastases \[mets\])
* International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant…
What they're measuring
1
Clinical benefit by Response Evaluation Criteria in Solid Tumors 1.1