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

Last updated on February 21, 2019

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Study Location
Scottsdale Healthcare
Scottsdale, Arizona, 85258 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced or Recurrent Solid Tumors, Breast Neoplasms, Epithelial Ovarian Cancer, Ewing Sarcoma, Small Cell Lung Carcinoma, Prostate Cancer, Pancreas Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01286987
Pfizer
Completed
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

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