A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors
NCT03343054
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- 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.
- First-line locally advanced or metastatic breast cancer with no prior neoadjuvant and
adjuvant chemotherapy.
- Prior treatment with a PARP inhibitor.
- Objective disease progression while receiving platinum chemotherapy administered for
locally advanced or metastatic disease.
- HER2 positive breast cancer.
- Active inflammatory breast cancer.
- Central nervous system (CNS) metastases.
- Current or anticipated use within 7 days prior to the first dose of study treatment,
or anticipated use during the study of strong P-gp inhibitors.
- Fertile male patients and female patients of childbearing potential who are unwilling
or unable to use 2 highly effective methods of contraception.
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Descriptive Information | |||||
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Brief Title ICMJE | A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors | ||||
Official Title ICMJE | A PHASE 1 STUDY OF THE SAFETY, PHARMACOKINETICS AND ANTI-TUMOR ACTIVITY OF TALAZOPARIB, POLY (ADP-RIBOSE) POLYMERASE (PARP) INHIBITOR, IN JAPANESE PATIENTS WITH ADVANCED SOLID TUMORS | ||||
Brief Summary | This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part. The dose escalation part is open-label, and evaluates safety, preliminary efficacy and PK of single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available. In the dose escalation part, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed DLTs. The expansion part is designed to assess the efficacy, safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations. In the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary endpoint. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: talazoparib
Talazoparib will be administered orally on a continuous basis. Talazoparib may be taken with or without food. Each cycle will consist of 28 days. | ||||
Study Arms ICMJE | Experimental: talazoparib
0.75 mg/day or 1.0 mg/day 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 | Active, not recruiting | ||||
Actual Enrollment ICMJE | 27 | ||||
Original Estimated Enrollment ICMJE | 18 | ||||
Estimated Study Completion Date ICMJE | December 28, 2022 | ||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | [Dose Escalation Part] Inclusion Criteria:
Exclusion Criteria:
[Dose Expansion Part] Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03343054 | ||||
Other Study ID Numbers ICMJE | C3441030 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |