NCT01574716已完成2 期
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Morphotek
- 入组人数
- 209
- 试验地点
- 29
- 主要终点
- Part 2: Radiologic Progression-free Survival (PFS)
研究概览
简要总结
This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be at least 18 years of age
- •Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
- •Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgrouped
- •Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. Prior anthracycline-based regimen is allowable but not required. Subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.)
- •Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization
- •Have tumor tissue available for TEM-1 biomarker studies
- •Be willing and able to provide written informed consent
排除标准
- •Have received more than 2 prior systemic treatment regimens for mSTS
- •Have received either gemcitabine or docetaxel in any previous treatment for mSTS (regardless of the line of treatment)
- •Have a diagnosis of primary bone sarcoma of any histological type.
- •Have a history of clinically significant heart disease, or clinically significant arrhythmia on ECG within the past 6 months
- •Have a history of allergic reaction to prior monoclonal antibody or biologic agent
- •Have received previous treatment with MORAb-004 (anti-TEM-1)
- •Have a medical condition with a high risk of bleeding (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event
- •Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study
- •Have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone fracture
研究组 & 干预措施
MORAb-004, gemcitabine, docetaxel
Experimental
干预措施: MORAb-004 (Drug)
MORAb-004, gemcitabine, docetaxel
Experimental
干预措施: Gemcitabine (Drug)
MORAb-004, gemcitabine, docetaxel
Experimental
干预措施: Docetaxel (Drug)
Placebo, gemcitabine, docetaxel
Active Comparator
干预措施: Gemcitabine (Drug)
Placebo, gemcitabine, docetaxel
Active Comparator
干预措施: Docetaxel (Drug)
Placebo, gemcitabine, docetaxel
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Part 2: Radiologic Progression-free Survival (PFS)
时间窗: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.
次要结局
- Part 2: Overall Response Rate (ORR)(From date of first dose until disease progression (up to approximately 3.5 years))
- Part 2: Symptomatic Progression-free Survival(From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years))
- Part 2: Radiologic Progression-free Survival Rate (PFR)(Weeks 12, 24, 48 and 52)
- Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels(Up to approximately 3 years)
- Part 2: Overall Survival (OS)(From date of first dose until date of death from any cause (up to approximately 3.5 years))
研究者
研究点 (29)
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