Phase I/prospective randomized phase II trial Of the Safety and Efficacy of tamoxifen in combination with the Isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alONe in hormone receptor positive, HER2 negative, metastatic breast cancer patients with prior exposure to endocrine treatment (POSEIDON trial) - Poseidon

KI-AV0 个研究点目标入组 322 人开始时间: 2014年10月1日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•Phase Ib (dose escalation)
•- Minimum age for inclusion 18 years
•Breast cancer patients with ER and/or PR positive tumours, or patients with other cancer types whom the investigator considers might benefit from endocrine therapy combined with PI3K inhibition (for example ovarian cancer and cancer of the uterus).
•Patients with WHO performance status = 2
•Adequate organ and marrow function
•Fasting glucose = 120 mg/dL (=6.66 mmol/L) and HbA1c = ULN.
•Randomized phase II:
•Pre- and Postmenopausal patients with histology-/cytology- proven ER and/or PR positive*, HER2 negative breast cancer, with recurrent or metastatic disease which has progressed on prior endocrine therapy. Premenopausal patients should also receive LHRH agonist
•Patient with WHO performance status = 2
•Adequate organ and marrow function
•Fasting glucose = 120 mg/dL (=6.66 mmol/L) and HbA1c = ULN.
•Patients must have either measurable or evaluable disease by RECIST criteria.
•Availability of a representative tumour tissue specimen
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•Exclusion Criteria
•Patients with premenopausal follicle stimulating hormone (FSH) and/or plasma estradiol levels who are not treated with a LHRH agonist
•More than 5 prior chemotherapeutic regimens for metastatic breast cancer
•Endocrine therapies or small molecule targeted (non-cytotoxic) inhibitors (including investigational kinase inhibitors) within 5 half-lives of the compund or active metabolites with a maximum of 4 weeks.
•Cytotoxic chemotherapy within 3 weeks, or nitrosoureas or mitomycin C within 6 weeks before the first dose of the study treatment
•Antibody therapy within 4 weeks before the first dose of the study treatment
•Radiation therapy within 2 weeks before the first dose of study treatment
•Untreated, symptomatic, or progressive brain metastases.
•PT/ INR (PTT) test results at screening > 1.3 x the laboratory upper limit of normal.
•Corticosteroid use equivalent to more than 10mg prednisone daily
•Patients with a history of
•- Thrombo-embolic disease, except if she is adequately treated with low molecular weight heparin, vit K antagonist or rivaroxbane. INR should be within target range
•- Crohn’s disease or ulcerative colitis or other forms of autoimmune colitis
•- Clinically significant cardiac or pulmonary dysfunction
•- Type 1 or 2 diabetes requiring daily anti-hyperglycaemic medication

发起方

KI-AV