EUCTR2015-001316-34-PL进行中（未招募）1 期
A Phase 1b (Open-Label) / Phase 2 (Randomized,Double-Blinded) Study Evaluating Gemcitabine andDocetaxel With or Without Olaratumab in the Treatment ofAdvanced Soft Tissue Sarcoma - ANNOUNCE 2
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
- 310
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
- •Patients at least 16 years of age, ECOG PS 0 to 1, gemcitabine, docetaxel, and olaratumab naïve, with histologically confirmed, locally advanced, unresectable or metastatic STS, and not amenable to curative treatment with surgery or radiotherapy. The patient may have no more than 2 prior lines of systemic therapies (neoadjuvant and adjuvant therapies will not be considered as a prior line of therapy) for locally advanced or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy. All previous anticancer treatments must have completed = 3 weeks (21 days) prior to first dose of study drug. In the phase 2 part, prior olaratumab/doxorubicin combination therapy in one prior treatment line is allowed. Prior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label. Prior olaratumab therapy must have included at least 2 full cycles of olaratumab/doxorubicin (i.e. a minimum of 4 doses of olaratumab). Patients who completed at least 2 cycles of combination olaratumab/doxorubicin therapy then discontinued doxorubicin due to toxicity or maximum dosing and proceeded to olaratumab monotherapy are eligible. The most recent dose of olaratumab must have been received within 180 days of randomization in this study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 174
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Patients with gastrointestinal stromal tumor or Kaposi’s sarcoma will be excluded. Patients previously enrolled in Study I5B-MC-JGDJ or any other blinded study with olaratumab are not eligible to participate in this trial.
研究者
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