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

Completed · Phase 1

Conditions studied: Advanced or Recurrent Solid Tumors, Breast Neoplasms, Ovarian Cancer, Epithelial, Ewing Sarcoma, Small Cell Lung Carcinoma, Prostate Cancer, Pancreas Cancer

In brief

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.

Key facts

Study ID

NCT01286987

Run by

Pfizer

People needed

113

Starts

2011-01-03

Expected to finish

2017-01-30

Last updated by the study team

2019-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scottsdale Healthcare — Scottsdale, Arizona, United States
• Virginia G. Piper Cancer Center Research Pharmacy — Scottsdale, Arizona, United States
• (IRB# 12-000131) Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• Westwood Bowyer Clinic, Peter Morton Medical Building — Los Angeles, California, United States
• Santa Monica - UCLA Medical Center & Orthopaedic Hospital — Santa Monica, California, United States
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
• IU Health Bloomington Hospital — Bloomington, Indiana, United States
• Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Investigational Drug Services — Indianapolis, Indiana, United States
• IU Health University Hospital — Indianapolis, Indiana, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Royal Marsden Hospital NHS Foundation Trust — Sutton, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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