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

This study has been completed.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01286987
First received: January 26, 2011
Last updated: July 28, 2017
Last verified: July 2017
January 26, 2011
July 28, 2017
January 3, 2011
March 31, 2015   (Final data collection date for primary outcome measure)
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) ]
The primary outcome of this study is to determine the maximum tolerated dose (MTD) of daily oral BMN 673 [ Time Frame: Assessed after each visit until completion of Part 1 (Estimated duration is 12-18 months) ]
Complete list of historical versions of study NCT01286987 on ClinicalTrials.gov Archive Site
  • 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) ]
  • 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 BMN 673 [ 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 postdose (AUC0-inf), are under the curve extrapolated to infinity (AUC0-last), half life (t1/2), systemic clearance (CL/f) and volume of ditribution (VZ/f)
  • Determine the Recommended Phase 2 Dose (RP2D) of oral daily BMN 673 [ Time Frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months) ]
  • Assess preliminary efficacy of BMN 673 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) ]
Not Provided
Not Provided
 
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
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
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.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced or Recurrent Solid Tumors
  • Breast Neoplasms
  • Ovarian Cancer, Epithelial
  • Ewing Sarcoma
  • Small Cell Lung Carcinoma
  • Prostate Cancer
  • Pancreas Cancer
Drug: Talazoparib
Oral capsule with multiple dosage forms given once daily
Other Names:
  • BMN 673
  • MDV3800
Experimental: Talazoparib
Intervention: Drug: Talazoparib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
January 30, 2017
March 31, 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT01286987
PRP-001
2010-023062-40 ( EudraCT Number )
C3441007 ( Other Identifier: Alias Study Number )
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Medical Director Medivation, Inc.
Pfizer
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP