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Trial record 1 of 1 for:    NCT03042910
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A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03042910
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 22, 2016
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date February 28, 2018
Actual Study Start Date  ICMJE October 13, 2016
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • Time-matched plasma PK concentration [ Time Frame: Baseline and days 1 and 22 ]
  • Pharmacokinetic samples will be taken on days 1 and 22. A linear mixed effects modeling approach will be used to examine the relationship between the change from baseline in QTc intervals (QTcF and QTcB) and the plasma concentration of talazoparib. [ Time Frame: Days 1 and 22 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03042910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug [ Time Frame: Anticipated in about 10 months following first patient enrolled ]
  • Time-matched change from baseline in QTc, (measured in milliseconds) corrected for HR based on the Bazett correction method (QTcB) method (∆QTcB) [ Time Frame: Anticipated in about 10 months following first patient enrolled ]
  • Maximum Plasma Concentration (Cmax) [ Time Frame: Days 1 and 22 ]
  • Area Under the Curve (AUC) [ Time Frame: Days 1 and 22 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1, Open-label Study To Assess The Effects Of Talazoparib On Cardiac Repolarization In Patients With Advanced Solid Tumors
Brief Summary This study is designed to evaluate the effects of talazoparib on cardiac repolarization in patients with advanced solid tumors with no available standard treatment options.
Detailed Description For further talazoparib treatment, patients must enroll and initiate continued talazoparib treatment in a separate open label extension study within 30 days after the last dose of study drug.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: Talazoparib
Talazoparib 1 mg orally once daily.
Other Names:
  • MDV3800
  • BMN673
Study Arms  ICMJE Experimental: Patients with advanced solid tumors
Talazoparib 1 mg daily
Intervention: Drug: Talazoparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2018)
38
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2017)
30
Actual Study Completion Date  ICMJE June 22, 2017
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. At least 18 years of age and willing and able to provide informed consent.
  2. Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the investigator.
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  4. Estimated life expectancy of ≥ 3 months.
  5. Able to swallow the study drug, have no known intolerance to the study drug or excipients, and comply with study requirements.
  6. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after last dose of study drug.
  7. Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of study drug through 105 days after last dose of study drug. Contraception should be considered for a nonpregnant female partner of childbearing potential.
  8. Male and female patients must agree not to donate sperm or eggs, respectively, from the first dose of study drug through 105 days and 45 days after the last dose of study drug, respectively.
  9. Female patients may not be breastfeeding at screening and must not breastfeed during study participation through 45 days after the last dose of study drug.

Exclusion Criteria:

  1. Use of antineoplastic therapies within 21 days before day 1.
  2. Use of any other investigational agent within 21 days before day 1.
  3. Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
  4. Electrolyte abnormality that has not responded to correction, including hypokalemia or hypocalcemia less than the lower limit of normal, or hyperkalemia or hypercalcemia greater than the upper limit of normal (ULN).
  5. Major surgery within 14 days before day 1.
  6. Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy.
  7. Clinically significant cardiovascular disease.
  8. Significant organ dysfunction.
  9. Gastrointestinal disorder affecting absorption.
  10. Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP.
  11. Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator or medical monitor.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03042910
Other Study ID Numbers  ICMJE MDV3800-14
C3441005 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2018

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