CompletedPhase 1NCT01286987

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

StatusCompleted
PhasePhase 1
U.S. locations15
SponsorPfizer
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Pfizer
Interventions being studied
Drug: Talazoparib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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