A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

Launched by PFIZER · Nov 11, 2017

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • \[Dose Escalation Part\]
• Inclusion Criteria:
• • 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 Criteria:
• • 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.
• Exclusion Criteria:
• • 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.