PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMICS AND ANTI-TUMOR ACTIVITY OF PF-06873600 AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY

Kawai Norisuke0 个研究点目标入组 155 人开始时间: 2023年9月5日最近更新: 2023年10月17日

试验速览

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•* 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)

•* 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

发起方

Kawai Norisuke