EUCTR2020-001757-40-BG进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer and prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy (Part 2A).
- •Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer and has not received a CDK 4/6 inhibitor as treatment as an adjuvant or as treatment is the advanced or metastatic setting and has also not received an aromatase inhibitor in the advanced or metastatic setting (prior adjuvant therapy with AI is permitted). One prior line of cytotoxic chemotherapy in the advanced or metastatic setting is allowed (Part 2B)
- •Have a diagnosis of Horne Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer and has not received a CDK 4/6 inhibitor as treatment as an adjuvant or as treatment is the advanced or metastatic setting. Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or peri-menopausal OR progressed while on or within 1 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if postmenopausal, or prior endocrine treatment for advanced/metastatic breast cancer if pre- or peri menopausal. One prior line of cytotoxic chemotherapy in the advanced or metastatic setting is allowed (Part 2C).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- •Measurable disease as defined by RECIST 1.1 is required
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
研究者
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