Advanced solid tumor
Conditions
Interventions
* Single Agent Dose Escalation: PF-06873600 tablet for oral dosing
* Part 1B: PF-06873600 tablet for oral dosing and Endocrine Therapy 1
* Part 1B: PF-06873600 tablet for oral dosing and Endocrine The
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Number of patients with dose limiting toxicities in the Dose Escalation portion * 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) observed in patients in the Dose Expansion Arms | — |
Secondary
| Measure | Time frame |
|---|---|
| * PK parameter of PF-06873600 * ORR per RECIST version 1.1 * Time-to-event endpoint * PD biomarkers (pRb and Ki67) in tumor tissue | — |
Countries
Bulgaria, Canada, Japan, Russian Federation, Ukraine, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed