Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.
Checked against the public recordLast updated Jan 10, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Drug: Talazoparib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Scottsdale HealthcareScottsdale, Arizona
- Virginia G. Piper Cancer Center Research PharmacyScottsdale, Arizona
- (IRB# 12-000131) Ronald Reagan UCLA Medical Center, Drug Information CenterLos Angeles, California
- Ronald Reagan UCLA Medical CenterLos Angeles, California
- UCLA Hematology/OncologyLos Angeles, California
- Westwood Bowyer Clinic, Peter Morton Medical BuildingLos Angeles, California
- Santa Monica - UCLA Medical Center & Orthopaedic HospitalSanta Monica, California
- UCLA Hematology/Oncology - Santa MonicaSanta Monica, California
- IU Health Bloomington HospitalBloomington, Indiana
- Indiana University Health Melvin and Bren Simon Cancer CenterIndianapolis, Indiana
- Investigational Drug ServicesIndianapolis, Indiana
- IU Health University HospitalIndianapolis, Indiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 10, 2019. Always confirm current availability with the study team.