Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

Inclusion Criteria

• •Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor
• •Must have available archived tumor tissue (formalin-fixed paraffin-embedded) \[FFPE\].
• •18 years of age or older.
• •Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer).
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• •Have adequate organ function
• •Able to take oral medications.
• •Willing and able to provide informed consent.
• •Sexually active patients must be willing to use an acceptable method of contraception.
• •Females of childbearing potential must have a negative serum pregnancy test at screening.
• •Willing and able to comply with all study procedures.
• •Part 2 Dose Expansion Tumor Types:
• •Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease.
• •Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease.
• •Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC.
• •Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease.