EUCTR2015-001316-34-IT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 of Advanced Soft Tissue Sarcoma - ANNOUNCE 2
ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 个研究点目标入组 310 人开始时间: 2021年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 received at most 2 previous lines of systemic therapy (neoadjuvant and adjuvant therapies will not be considered as prior therapy) for locally advanced or metastatic disease and is suitable for receiving gentamicitabine and docetaxel therapy. antitumor should be completed more than 3 weeks (= 3 weeks (21 days)) before receiving the first dose of study medication.
- •In phase 2 the previous combination therapy with olaratumab / doxorubicin in a treatment line is allowed.
- •Previous olaratumeb therapy must have been with doxorubicin as indicated on the olaratumab label.
- •Prior therapy with olaratumab must have included at least 2 complete cycles of olaratumab / doxorubicin (ie a minimum of 4 doses of oloratumab).
- •Patients who have completed at least 2 courses of therapy with olaratumab / doxorubicin in combination and who have suspended doxorubicin due to maximum toxicity or dose and continued with olaratumab as monotherapy are still suitable. the last most recent dose of olaratumab must have been taken within 180 days of randomization in this study.
- •Are the trial subjects under 18? yes
- •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 172
- •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.
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