EUCTR2012-000335-11-CZ进行中（未招募）1 期
A Phase 2 Randomized Trial of the Combination of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in High Proliferation, Estrogen Receptor Positive Breast Cancer Patients - A phase IIb study of ridaforolimus, dalotzumab and exemestane in combination in advanced breast canc
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
入选标准
- •1.Metastatic, ER positive, HER2 negative Breast Cancer
- •2.High Proliferative (as measured by a Ki67 labeling index >15%)
- •3.Post menopausal
- •4.Previous treatment with either letrozole or anastrozole
- •5.AT least 1 measurable lesion
- •6.At least 18 years of age
- •7.Greater than or equal to 1 on the ECOG performance status.
- •8.Life expectance greater than 3 months
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1.Patient is on other therapy for their cancer (Bisphosphonates and denosumab for the treatment of bone metastases are allowed, if they were initiated at least 28 days prior to randomization.)
- •2.Patient is in another study or is receiving an experimental agent.
- •3.Patient has previously received rapamycin or rapamycin analogs, including ridaforolimus, temsirolimus, or everolimus.
- •4.Patient has received prior treatment with IGF-1R inhibitors, PI3K inhibitors, or other experimental agents that target PI3K, AKT, or mTOR pathway
- •5.Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks [(6 weeks for nitrosoureas, mitomycin C, or bevacizumab and 2 weeks for hormonal therapy and kinase inhibitors)] prior to entering the study or who has not recovered from adverse events from prior treatment to at least grade 1 or baseline.
- •6.Patient has active brain metastasis or leptomeningeal carcinomatosis;
- •7.Patient has poorly controlled Type 1 or 2 diabetes, defined as a hemoglobin A1C greater than 8% or a fasting glucose of > 160 mg/dL.
- •8.Patient is known to be HIV positive.
- •9.Patient has a known history of active Hepatitis B or C. Patients who are seropositive for Hepatitis B surface antibody as their only evidence of prior hepatitis exposure are allowed.
- •10.Patient has a requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A). Patients should be off these medications for at least 2 weeks prior to the first dose of ridaforolimus. Concomitant medications that are metabolized by CYP3A are allowed (e.g., simvastatin or atorvastatin). See Appendix 6.1 for examples of CYP3A inducers and inhibitors.
研究者
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