STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS
NCT04635631
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Histological or cytological diagnosis of locally advanced or metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
- ECOG Performance Status 0 or 1.
- Adequate Bone Marrow, Renal and Liver Function.
- Participants with brain metastases.
- Current or anticipated use of P gp inhibitor and/or inducer within 7 days prior to
study intervention from lead-in to end of Cycle 1; concomitant use of potent P gp
inhibitor after Cycle 1 until the end of treatment.
- Prior treatment with a PARP inhibitor.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Changchun, Jilin
- Beijing,
- Duarte, California
- Creve Coeur, Missouri
- Florissant, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Saint Peters, Missouri
- Germantown, Tennessee
- Memphis, Tennessee
- Houston, Texas
- Houston, Texas
- Woodville, South Australia
- Clayton, Victoria
- Melbourne, Victoria
- Madison, Wisconsin
- Minneapolis, Minnesota
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS | ||||
Official Title ICMJE | AN OPEN-LABEL, SINGLE-ARM, PHASE 1 STUDY OF PHARMACOKINETICS, SAFETY AND ANTI-TUMOR ACTIVITY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS | ||||
Brief Summary | A phase1 study to evaluate the PK (single dose and multiple doses) and safety of talazoparib 1 mg Once Daily in Chinese adult participants with advanced solid tumors. A maximum of approximately 15 participants will be enrolled such that approximately 12 evaluable participants complete the study. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Neoplasms | ||||
Intervention ICMJE | Drug: talazoparib
Talazoparib will be administered orally on a continuous basis. Each cycle will consist of 28 days. | ||||
Study Arms ICMJE | Not Provided | ||||
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 | 15 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | April 2, 2022 | ||||
Estimated Primary Completion Date | November 12, 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 | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04635631 | ||||
Other Study ID Numbers ICMJE | C3441049 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
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 |