Clinical Trials /

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

NCT02997176

Description:

This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: MDV3800-02
  • SECONDARY ID: C3441002
  • NCT ID: NCT02997176

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
TalazoparibMDV3800, BMN673Group A (control, normal hepatic function)

Purpose

This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.

Detailed Description

      At 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.
    

Trial Arms

NameTypeDescriptionInterventions
Group A (control, normal hepatic function)Experimental
  • Talazoparib
Group B (mild hepatic dysfunction)Experimental
  • Talazoparib
Group C (moderate hepatic dysfunction)Experimental
  • Talazoparib
Group D (severe hepatic dysfunction)Experimental
  • Talazoparib

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pharmacokinetics of talazoparib as assessed by trough plasma concentrations
Time Frame:Anticipated in about 1 year following first patient enrolled
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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 1 year following first patient enrolled
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Last Updated