Clinical Trials /

Open-Label Extension and Safety Study of Talazoparib

NCT02921919

Description:

This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

Related Conditions:
  • Cancer
Recruiting Status:

Enrolling by invitation

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Open-Label Extension and Safety Study of Talazoparib
  • Official Title: A SINGLE-ARM, OPEN-LABEL, MULTICENTER, EXTENDED TREATMENT, SAFETY STUDY IN PATIENTS TREATED WITH TALAZOPARIB

Clinical Trial IDs

  • ORG STUDY ID: MDV3800-13
  • SECONDARY ID: C3441010
  • SECONDARY ID: 2016-001972-31
  • NCT ID: NCT02921919

Conditions

  • Cancer

Interventions

DrugSynonymsArms
TalazoparibMDV3800Talazoparib

Purpose

This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

Trial Arms

NameTypeDescriptionInterventions
TalazoparibExperimental
  • Talazoparib

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          -  Female patients of childbearing potential must have a negative pregnancy test before
             the first dose of talazoparib and must agree to use a highly effective birth control
             method from the time of the first dose of talazoparib through 45 days after the last
             dose.

          -  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 talazoparib through 105
             days after the last dose. Contraception should be considered for a nonpregnant female
             partner of childbearing potential.

          -  Female patients may not be breastfeeding at the first dose of talazoparib and must not
             breastfeed during study participation through 45 days after the last dose of
             talazoparib.

        Exclusion Criteria:

          -  Permanently discontinued from any Medivation sponsored study with talazoparib alone or
             in combination with another agent.

          -  Received an antineoplastic therapy or investigational agent after treatment with
             talazoparib in the originating protocol.

          -  Has a clinically significant cardiovascular, dermatologic, endocrine,
             gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or
             pulmonary disorder or any other condition, including excessive alcohol or drug abuse,
             or secondary malignancy, that may interfere with study participation in the opinion of
             the investigator.

          -  Diagnosis of myelodysplastic syndrome (MDS).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary 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 52 months following first patient enrolled
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

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