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.

Exclusion Criteria:

- Part 2 Expansion: Prior treatment with a PARP inhibitor.

- Has history of central nervous system (CNS) metastasis.

* Exception: In patients with SCLC, history of adequately treated brain metastasis who
do not require corticosteroids for management of CNS symptoms.

- Has had major surgery within 28 days before Cycle 1, Day 1.

- Has active peptic ulcer disease.

- Active gastrointestinal tract disease with malabsorption syndrome.

- Pregnant or breastfeeding at screening or planning to become pregnant (in each case,
either oneself or one's partner) at any time during the study.