A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors

NCT03042910

Last updated date
Study Location
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
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
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2019

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