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Trial record 1 of 1 for:    NCT01286987
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Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286987
First Posted: February 1, 2011
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Advanced or Recurrent Solid Tumors Breast Neoplasms Ovarian Cancer, Epithelial Ewing Sarcoma Small Cell Lung Carcinoma Prostate Cancer Pancreas Cancer Drug: Talazoparib Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary outcome of this study is to determine the maximum tolerated dose (MTD) of daily oral talazoparib [ Time Frame: Assessed after each visit until completion of Part 1 (Estimated duration is 12-18 months) ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months) ]
  • Determine the pharmacokinetic (PK) profile of talazoparib [ Time Frame: Assessed at each visit in cycle 1 - 5 (Estimated duration is 24 months) ]
    Sample collection times vary per visit. PK parameters that will be evaluated include: maximum concentration (Cmax), minimum concentration (Cmin), time to maximum plasma concentration (Tmax), area under the curve from 0 to last quantifiable sampling point post-dose (AUC0-inf), are under the curve extrapolated to infinity (AUC0-last), half life (t1/2), systemic clearance (CL/f) and volume of distribution (VZ/f)

  • Determine the Recommended Phase 2 Dose (RP2D) of oral daily talazoparib [ Time Frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months) ]
  • Assess preliminary efficacy of talazoparib by Response Rate, based on RECIST (Response Evaluation Criteria In Solid Tumors) [ Time Frame: Assessed approximately every 8 weeks (Estimated duration is 24-30 months) ]

Enrollment: 113
Actual Study Start Date: January 3, 2011
Study Completion Date: January 30, 2017
Primary Completion Date: March 31, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Talazoparib Drug: Talazoparib
Oral capsule with multiple dosage forms given once daily
Other Names:
  • BMN 673
  • MDV3800

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286987


Locations
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
Virginia G. Piper Cancer Center Research Pharmacy
Scottsdale, Arizona, United States, 85258
United States, California
(IRB# 12-000131) Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
Westwood Bowyer Clinic, Peter Morton Medical Building
Los Angeles, California, United States, 90095
Santa Monica - UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, United States, 90404
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States, 90404
United States, Indiana
IU Health Bloomington Hospital
Bloomington, Indiana, United States, 47403
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Investigational Drug Services
Indianapolis, Indiana, United States, 46202
IU Health University Hospital
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
United States, Texas
The University of Texas MD Anderson Cancer Center, Investigational Pharmacy Services
Houston, Texas, United States, 77030-4009
United Kingdom
Royal Marsden Hospital NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Medical Director Medivation, Inc.
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01286987     History of Changes
Other Study ID Numbers: PRP-001
2010-023062-40 ( EudraCT Number )
C3441007 ( Other Identifier: Alias Study Number )
First Submitted: January 26, 2011
First Posted: February 1, 2011
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Pfizer:
BRCA1 Protein
BRCA2 Protein

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Sarcoma, Ewing
Pancreatic Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ovarian Diseases
Adnexal Diseases