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Adult Trials: 18+ Years
- 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.
- 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).
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Open-Label Extension and Safety Study of Talazoparib | ||||||
| Official Title ICMJE | A SINGLE-ARM, OPEN-LABEL, MULTICENTER, EXTENDED TREATMENT, SAFETY STUDY IN PATIENTS TREATED WITH TALAZOPARIB | ||||||
| Brief Summary | This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Cancer | ||||||
| Intervention ICMJE | Drug: Talazoparib
Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol Other Name: MDV3800 | ||||||
| Study Arms ICMJE | Experimental: Talazoparib
Intervention: Drug: Talazoparib | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE | 150 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | May 31, 2021 | ||||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
| ||||||
| Listed Location Countries ICMJE | Canada, France, Germany, Hungary, Moldova, Republic of, Poland, Russian Federation, United Kingdom, United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT02921919 | ||||||
| Other Study ID Numbers ICMJE | MDV3800-13 C3441010 ( Other Identifier: Alias Study Number ) 2016-001972-31 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Medivation, Inc. | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||