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An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)

Last updated on November 15, 2019

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Study Location
UCLA Hematology/Oncology - Alhambra
Alhambra, California, 91801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
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. Signed and dated Informed Consent Form (by the patient or a legally acceptable
representative as per the local regulations).

2. Female or male at least 18 years of age.

3. Histologically or cytologically confirmed advanced solid tumor with no available
standard treatment options in the opinion of the Investigator

4. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.

5. Expected life expectancy of ≥ 3 months.

6. Able to swallow the study drug (no contraindication to oral agents).

7. Hepatic function at screening and enrollment as defined by the NCI organ dysfunction
working group (NCI-ODWG) criteria.

8. Adequate other organ function at screening and enrollment.

9. Female patients of childbearing potential must have a negative serum pregnancy test at
screening and must agree to use a highly effective form of contraception from the time
of the first dose of study drug through 45 days after the last dose of study drug.

10. Male patients must agree to use a condom when having sex with a pregnant woman or with
a non-pregnant female partner of childbearing potential, from 21 days before the first
dose of study drug through 105 days after last dose of study drug.

11. Female patients must not be breastfeeding at screening nor during the study
participation until 45 days after the last dose of the study drug.

12. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other trial procedures.

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

1. Treatment within 14 days or five half lives prior to enrollment whichever is longer
with any type of systemic anticancer-therapy or any investigational drug

2. Have not recovered (recovery is defined as CTCAE grade ? 1) from the acute toxicities
of previous anticancer standard or investigational therapy, except treatment-related
alopecia or laboratory abnormalities otherwise meeting eligibility requirements.

3. Major surgery within 28 days prior to enrollment.

4. Serious accompanying cardiac disorder

5. Active known or suspected brain metastasis or active leptomeningeal disease needing
treatment

6. Symptomatic or impending spinal cord compression or cauda equine syndrome

7. Has undergone a liver transplant, kidney transplant or nephrectomy.

8. Prior allergic reaction or severe intolerance (meeting the criteria for a serious
adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly
ADP ribose polymerase (PARP) inhibitor.

9. Known myelodysplastic syndrome

10. Seropositive for human immunodeficiency virus (HIV).

11. Any serious or unstable medical condition that interferes with ability to tolerate
treatment or assessments associated with the protocol.

12. Gastrointestinal disorder affecting absorption.

13. Known or suspected hypersensitivity to any of the talazoparib capsule components.

14. Any condition or reason that interferes with ability to participate in the study,
tolerate treatment or assessments associated with the protocol, causes undue risk, or
complicates the interpretation of safety data, in the opinion of the Investigator or
Medical Monitor

NCT02997176
Pfizer
Recruiting
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)

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Descriptive Information
Brief Title  ICMJE An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
Official Title  ICMJE A PHASE I OPEN-LABEL PHARMACOKINETICS AND SAFETY STUDY OF TALAZOPARIB (MDV3800) IN PATIENTS WITH ADVANCED SOLID TUMORS AND NORMAL OR VARYING DEGREES OF HEPATIC IMPAIRMENT
Brief SummaryThis is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.
Detailed DescriptionAt the end of the study, patients with no clinically significant toxicities, no contraindications to continue treatment with talazoparib, and no disease progression (underlying cancer progression) may be eligible to continue talazoparib treatment in a separate open-label extension study. The decision to allow the patient to continue dosing with talazoparib in an open-label extension (OLE) study will be based on potential overall benefit-risk and patient meeting eligibility criteria for OLE.
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 Advanced Solid Tumors
Intervention  ICMJE Drug: Talazoparib
Daily oral doses of talazoparib 0.5 mg
Other Names:
  • MDV3800
  • BMN673
Study Arms  ICMJE
  • Experimental: Group A (control, normal hepatic function)
    Intervention: Drug: Talazoparib
  • Experimental: Group B (mild hepatic dysfunction)
    Intervention: Drug: Talazoparib
  • Experimental: Group C (moderate hepatic dysfunction)
    Intervention: Drug: Talazoparib
  • Experimental: Group D (severe hepatic dysfunction)
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 15, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 27, 2020
Estimated Primary Completion DateMay 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed and dated Informed Consent Form (by the patient or a legally acceptable representative as per the local regulations).
  2. Female or male at least 18 years of age.
  3. Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the Investigator
  4. Eastern Cooperative Oncology Group (ECOG) Performance status ? 2.
  5. Expected life expectancy of ? 3 months.
  6. Able to swallow the study drug (no contraindication to oral agents).
  7. Hepatic function at screening and enrollment as defined by the NCI organ dysfunction working group (NCI-ODWG) criteria.
  8. Adequate other organ function at screening and enrollment.
  9. Female patients of childbearing potential must have a negative serum pregnancy test at screening and must agree to use a highly effective form of contraception from the time of the first dose of study drug through 7 months after the last dose of study drug.
  10. Male patients must agree to use a condom when having sex with a pregnant woman or with a non-pregnant female partner of childbearing potential, from 21 days before the first dose of study drug through 4 months after last dose of study drug.
  11. Female patients must not be breastfeeding at screening nor during the study participation until 7 months after the last dose of the study drug.
  12. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

  1. Treatment within 14 days or five half lives prior to enrollment whichever is longer with any type of systemic anticancer-therapy or any investigational drug
  2. Have not recovered (recovery is defined as CTCAE grade ? 1) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
  3. Major surgery within 28 days prior to enrollment.
  4. Serious accompanying cardiac disorder
  5. Active known or suspected brain metastasis or active leptomeningeal disease needing treatment
  6. Symptomatic or impending spinal cord compression or cauda equine syndrome
  7. Has undergone a liver transplant, kidney transplant or nephrectomy.
  8. Prior allergic reaction or severe intolerance (meeting the criteria for a serious adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly ADP ribose polymerase (PARP) inhibitor.
  9. Known myelodysplastic syndrome
  10. Seropositive for human immunodeficiency virus (HIV).
  11. Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
  12. Gastrointestinal disorder affecting absorption.
  13. Known or suspected hypersensitivity to any of the talazoparib capsule components.
  14. Any condition or reason that interferes with ability to participate in the study, tolerate treatment or assessments associated with the protocol, 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: Pfizer Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02997176
Other Study ID Numbers  ICMJE MDV3800-02
C3441002 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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