Open-Label Extension and Safety Study of Talazoparib
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02921919 |
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Recruitment Status :
Enrolling by invitation
First Posted : October 3, 2016
Last Update Posted : March 18, 2020
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Sponsor:
Pfizer
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
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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 : | September 30, 2020 |
| Estimated Study Completion Date : | September 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 :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
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 ClinicalTrials.gov identifier (NCT number): NCT02921919
Locations
Show 44 study locations
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
| Study Director: | Pfizer Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT02921919 |
| 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: | March 18, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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/data_requests. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Additional relevant MeSH terms:
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Talazoparib Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |