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

This study has been completed.
Information provided by (Responsible Party):
Medivation, Inc. Identifier:
First received: January 26, 2011
Last updated: July 14, 2017
Last verified: July 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1, First in Human, Single-arm, Open-label Study of Once a Day, Orally Administered Talazoparib in Patients With Advanced or Recurrent Solid Tumors

Resource links provided by NLM:

Further study details as provided by Medivation, Inc.:

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: 74
Study Start Date: December 2010
Study Completion Date: January 2017
Primary Completion Date: March 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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01286987

United States, Arizona
TGen Clinical Research Services
Scottsdale, Arizona, United States, 95258
United States, California
University of California Los Angeles (UCLA)
Santa Monica, California, United States, 90404
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Medivation, Inc.
Study Director: Medical Director Medivation, Inc.
  More Information

Responsible Party: Medivation, Inc. Identifier: NCT01286987     History of Changes
Other Study ID Numbers: PRP-001
Study First Received: January 26, 2011
Last Updated: July 14, 2017

Keywords provided by Medivation, Inc.:
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
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ovarian Diseases
Adnexal Diseases processed this record on July 26, 2017