Open-Label Extension and Safety Study of Talazoparib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02921919
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : November 12, 2018
Medivation, Inc.
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Cancer Drug: Talazoparib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label, Multicenter, Extended Treatment, Safety Study In Patients Treated With Talazoparib
Actual Study Start Date : November 8, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Talazoparib Drug: Talazoparib
Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol
Other Name: MDV3800

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02921919

Contact: Pfizer Pfizer Call Center 1-800-718-1021

  Show 50 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Study Director: Pfizer Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT02921919     History of Changes
Other Study ID Numbers: MDV3800-13
C3441010 ( Other Identifier: Alias Study Number )
2016-001972-31 ( EudraCT Number )
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents