Multicenter, Triple-arm, Single-stage, Phase II Trial to Determine the Preliminary Efficacy and Safety of RAD001 in Patients With Histological Evidence of Progressive or Metastatic Bone or Soft Tissue Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Best Overall Response Rates by Week 16 (ITT)
研究概览
简要总结
The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histological evidence of progressive or metastatic bone or soft tissue sarcoma.
- •The following tumor types are included:
- •malignant fibrous histiocytoma
- •liposarcoma
- •synovial sarcoma
- •malignant paraganglioma
- •fibrosarcoma
- •leiomyosarcoma
- •angiosarcoma including haemangiopericytoma
- •malignant peripheral nerve sheath tumor
- •STS, not otherwise specified
- •miscellaneous sarcoma including mixed mesodermal tumors of the uterus
- •osteosarcoma
- •Ewing's sarcoma
- •rhabdomyosarcoma
- •gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line)
- •alveolar soft part sarcoma (ASPS)
- •Objective progression of disease may be documented by RECIST criteria. Any of the following would be sufficient according to RECIST:
- •a 20% increase in the sum of unidimensionally measured target lesions
- •a new lesion
- •unequivocal increase in non-measurable disease.
- •Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
- •ECOG performance status 0 - 2.
排除标准
- •Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.
- •The following tumor types will not be included:
- •gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line)
- •chondrosarcoma
- •malignant mesothelioma
- •neuroblastoma.
- •Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
- •Neurotoxicity > grade 2 CTC.
- •Radiation of the lung.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Arm 1
Progressive or metastatic bone or soft tissue sarcomas
干预措施: Everolimus (Drug)
Arm 2
Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line
干预措施: Everolimus (Drug)
Arm 3
Progressive or metastatic alveolar soft part sarcoma (ASPS)
干预措施: Everolimus (Drug)
结局指标
主要结局
Best Overall Response Rates by Week 16 (ITT)
时间窗: Baseline up to 16 weeks
The best overall response is the best response recorded from treatment start until disease progression/recurrence (both measurement and confirmation criteria). Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions): Complete Response (CR)=at least two determinations of CR 4 weeks apart before progression, Partial Response (PR)=at least two determinations of CR 4 weeks apart before progression (and not qualifying for a CR), Stable Disease (SD)=at least one SD assessment \>6 weeks after start of treatment and Progressive Disease (PD)=Progression or death due to underlying cancer ≤16 weeks after start of treatment. PD without radiologic evidence were classified as progression only, when clear evidence of clinical deterioration was available and patient discontinued due to "disease progression". Unknown (UNK) = all other cases.
次要结局
- Time to Progression (TTP) (ITT)(Baseline up to 16 weeks)
- Percentage of Participants With Overall Survival (OS) at Week 16 (ITT)(Baseline up to 16 weeks)
- Objective Tumor Response Rates (Complete Response and Partial Response) at Week 16 (ITT)(Baseline up to approximately 16 weeks)
- Percentage of Participants With Progression-free Survival (PFS) at 16 Weeks(16 weeks)
- Percentage of Participants With Duration of Response (CR, PR, SD) at 16 Weeks.(Baseline up to 16 weeks)