A Study of PF-06873600 in People With Cancer
Completed
- Conditions
- Advanced solid tumor
- Registration Number
- jRCT2031230326
- Lead Sponsor
- Pfizer Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 155
Inclusion Criteria
- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer (prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy)
- Have a diagnosis of metastatic triple negative breast cancer (TNBC) (up to 1-2 prior lines of chemotherapy)
- Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (up to 2-3 prior lines of therapy)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
- Measurable disease as defined by RECIST 1.1 is required (Part 1B and Part 2 only)
Exclusion Criteria
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study entry
- Last anti-cancer treatment within 2 weeks prior to study entry
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Pregnant or breastfeeding female patients
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Number of patients with dose limiting toxicities Number of patients with dose limiting toxicities in the Dose Escalation portion
Safety and Tolerability Safety and Tolerability as assessed by adverse event, safety laboratory abnormalities (hematology, chemistry, coagulation and urinalysis), vital signs and heart rate corrected QT interval
Objective Response Rate (ORR) Objective Response Rate (ORR) observed in patients in the Dose Expansion Arms
- Secondary Outcome Measures
Name Time Method