Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
NCT ID: NCT01286987
Last Updated: 2019-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
113 participants
INTERVENTIONAL
2011-01-03
2017-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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Talazoparib
Talazoparib
Oral capsule with multiple dosage forms given once daily
Interventions
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Talazoparib
Oral capsule with multiple dosage forms given once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Medivation, Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Medical Director
Role: STUDY_DIRECTOR
Medivation, Inc.
Locations
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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
Countries
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Other Identifiers
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2010-023062-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3441007
Identifier Type: OTHER
Identifier Source: secondary_id
PRP-001
Identifier Type: -
Identifier Source: org_study_id
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