NCT01296659撤回1 期
Phase Ib Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Patients With Advanced Unresectable Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Define maximum tolerated dose (MTD)
研究概览
简要总结
Ridaforolimus has been tested in almost 2 dozen studies; however, it has not previously been tested in combination with the standard of care chemotherapy for sarcoma as this study will. We will be looking to see if Ridaforolimus given with SOC chemo (AIM or TG) is well tolerated and to determine a Phase 2 dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or metastatic soft tissue sarcoma with histological or cytological proven disease. No more than 2 lines of chemotherapy in the metastatic setting in the dose escalation phase, and no more than one line of prior therapy in the expansion phase.
- •ECOG performance status of ≤ 1
- •A minimum life expectancy > 3 months
- •At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy or radiotherapy and the first dose of ridaforolimus
- •Adequate hematological, hepatic and renal function (hemoglobin ≥ 9g/dl, absolute neutrophil count [ANC] ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; bilirubin ≤ ULN; alkaline phosphatase ≤ 2.5 x ULN; AST, ALT ≤ 2.5 x ULN; albumin ≥ 2.5mg/dL; creatinine ≤ 1.5 x ULN)
- •Serum cholesterol ≤ 350 mg/dL and triglycerides ≤400 mg/dL
- •Signed informed consent
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of therapy and must use an approved contraceptive method as appropriate from the time of screening until 30 days after the last dose of study drug.
排除标准
- •Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.
- •Clinically significant unexplained bleeding within 28 days prior to entering the trial
- •Uncontrolled systemic vascular hypertension
- •Clinically significant cardiovascular disease
- •Newly diagnosed (within 3 months of enrollment) or poorly controlled type 1 or 2 diabetes
- •Have received >350 mg/m2 total dose of Doxorubicin
- •Active infection requiring prescribed intervention
- •Other concurrent illness
- •Major surgery within 28 days before trial entry, or incompletely healed surgical incision; minor surgery or procedures within 7 days
- •Previous anthracycline lifetime exposure more than 350 mg/m2 would exclude patient form AIM Arm enrollment
- •Pregnant or breastfeeding
- •Known allergy to macrolide antibiotics
- •Concurrent treatment with medications that induce or inhibit cytochrome P450 (CYP3A).
- •Known history of HIV sero-positivity
研究组 & 干预措施
AIM Arm
Experimental
Ridaforolimus combined with doxorubicin/ifosfamide/mesma (AIM)
干预措施: ridaforolimus (Drug)
TG Arm
Experimental
Ridaforolimus combined with docetaxel and gemcitabine (TG)
干预措施: ridaforolimus (Drug)
结局指标
主要结局
Define maximum tolerated dose (MTD)
时间窗: 12-18 months
Defining the maximum tolerated dose (MTD) and recommended Phase II dose for the combination ridaforolimus and SOC chemotherapy
次要结局
- Number of Grade 2 or higher side effects with the combined therapy.(12-18 months)
- Pharmacokinetics(12-18 months)
研究者
研究点 (1)
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