Solid tumor Breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Talazoparib
INN of investigational material : Talazoparib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
Pfizer R&D Japan G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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. [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
Exclusion criteria: [Dose Escalation Part] 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] 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Efficacy Dose Escalation: Dose-Limiting Toxicities (28 days from baseline) Doaw Expansion: Confirmed Objective Response (From baseline until disease progression or death) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Efficacy Parmacokinetics Dose Escalation: - Cmax, AUC, t1/2, Tmax, Ctrough - OR, PFS - AE Dose Expansion: - Ctrough - TTR, DC, PFS, OS - AE | — |
Countries
Japan
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed