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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTalazoparib

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 10, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Pfizer
Interventions being studied: Drug: Talazoparib

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How this study is categorized

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

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

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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