Status:
COMPLETED
A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Neoplasms
Breast Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- \[Dose Escalation Part\]
- 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.
Exclusion
- Patients with known symptomatic brain metastases requiring steroids.
- Current use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP within 1 week or 5 half lives which ever is longer prior to the first dose of study treatment.
- Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception.
- \[Dose Expansion Part\]
- Inclusion Criteria:
- Histologically or cytologically confirmed carcinoma of the breast.
- Locally advanced breast cancer that is not amenable to curative radiation or surgery and/or metastatic disease.
- Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation by Myriad Genetics' BRACAnalysis CDx test.
- No more than 3 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease.
- Have measurable lesion by the RECIST v.1.1.
- ECOG Performance Status 0-2.
- Adequate Bone Marrow, Renal and Liver Function.
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03343054
Start Date
November 30 2017
End Date
July 18 2024
Last Update
August 22 2024
Active Locations (8)
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1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
2
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
3
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
4
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515