Phase 2
Completed N=118
Open-Label Extension and Safety Study of Talazoparib
Source: ClinicalTrials.gov NCT02921919 ↗Enrolled (actual)
118
Serious AEs
38.1%
Results posted
Aug 2022
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs — 63; 47; 27; 18 Participants
Summary
This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs |
63; 47; 27; 18; 45; 31 | — |
| PRIMARY Number of Participants With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4 |
38; 32 | — |
| PRIMARY Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death |
6; 7; 5; 4; 7; 7 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests |
5; 2; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters |
7; 16; 0; 0; 5; 2 | — |
| PRIMARY Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters |
5; 1; 1; 0; 3; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs and Weight |
1; 0; 1; 0; 0; 0 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02921919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.