Clinical Trials /

An Open-Label Pharmacokinetics and Safety Study of Talazoparib

NCT02997163

Description:

This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients with advanced solid tumors and impaired renal function.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: An Open-Label Pharmacokinetics and Safety Study of Talazoparib
  • 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 RENAL IMPAIRMENT

Clinical Trial IDs

  • ORG STUDY ID: MDV3800-01
  • SECONDARY ID: C3441001
  • SECONDARY ID: 2016-002536-33
  • NCT ID: NCT02997163

Conditions

  • Advanced Solid Tumors

Interventions

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

Purpose

This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients with advanced solid tumors and impaired renal 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 after discussion with the Principal Investigator and
      obtaining Sponsor permission. Sponsor decision to allow the patient to continue dosing with
      talazoparib in an open-label extension study will be based on potential overall benefit-risk,
      patient acceptance and other relevant criteria.
    

Trial Arms

NameTypeDescriptionInterventions
Group A (control, normal renal function)Experimental
  • Talazoparib
Group B (mild renal impairment)Experimental
  • Talazoparib
Group C (moderate renal impairment)Experimental
  • Talazoparib
Group D (severe renal impairment)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) obtained prior to initiation of any
             study-specific procedure and treatment.

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

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

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

          5. Expected life expectancy of ≥ 3 months.

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

          7. Renal function at screening and enrollment as defined by the Modification of Diet in
             Renal Disease (MDRD) equation.

          8. Patient has had no clinically significant change in renal status within 3 months prior
             to screening, according to Investigator's review of clinical patient records.

          9. Patient is not currently on hemodialysis and/or peritoneal dialysis for management of
             chronic kidney disease or acute failure/conditions.

         10. Patient has no unstable renal function, defined as a change in estimated glomerular
             filtration rate (eGFR) (calculated with the MDRD equation) of > 25% for patients with
             mild and moderate renal impaired or as a change in eGFR > 30% for patients with severe
             renal impaired, from screening to enrollment.

         11. Adequate other organ function at screening and enrollment.

         12. Female patients of childbearing potential must have a negative serum 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 the last dose of study drug.

         13. 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.

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

         15. 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 with any type of
             systemic anticancer-therapy or any investigational drug, whichever is longer.

          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 undergoing
             or requiring treatment.

          6. Symptomatic or impending spinal cord compression or cauda equina 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:Completed
Lead Sponsor:Pfizer

Last Updated

July 17, 2019