Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 104
- 主要终点
- Adverse events, laboratory parameters, vital signs
研究概览
简要总结
This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets of patients who are eligible for the study: untreated, treated and requiring further treatment, or treated and failed and for whom adding R1507 represents a suitable treatment for their disease. All regimens will first test doses of R1507 which are less than the maximally administered dose, and if tolerated, the dose will be escalated in subsequent patients. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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
- •adult patients, >=18 years of age;
- •malignant neoplasms;
- •failed prior standard curative therapy;
- •ECOG performance Status of 0 or 1;
- •adequate bone marrow, hepatic and renal function;
- •life expectancy greater than 8 weeks.
排除标准
- •chemotherapy within 2 weeks of start of therapy;
- •prior irradiation within 4 weeks prior to start of therapy;
- •prior treatment with agents targeting IGF-IR inhibition, or other investigational agents;
- •major surgery or significant traumatic injury within 2 weeks prior to study start;
- •patients receiving concurrent antibody or immunotherapy;
- •other exclusion criteria are related to specific treatment regimens.
研究组 & 干预措施
7
干预措施: erlotinib [Tarceva] (Drug)
10
干预措施: temozolomide (Drug)
1
干预措施: RG1507 (Drug)
1
干预措施: erlotinib [Tarceva] (Drug)
1
干预措施: gemcitabine (Drug)
10
干预措施: RG1507 (Drug)
11
干预措施: RG1507 (Drug)
11
干预措施: bevacizumab [Avastin] (Drug)
11
干预措施: docetaxel (Drug)
12
干预措施: RG1507 (Drug)
12
干预措施: pemetrexel (Drug)
13
干预措施: RO1507 (Drug)
2
干预措施: RG1507 (Drug)
2
干预措施: bevacizumab [Avastin] (Drug)
2
干预措施: paclitaxel (Drug)
3
干预措施: RG1507 (Drug)
3
干预措施: carboplatin (Drug)
3
干预措施: etoposide (Drug)
4
干预措施: RG1507 (Drug)
4
干预措施: bevacizumab [Avastin] (Drug)
4
干预措施: mFOLFOX6 (Drug)
5
干预措施: RG1507 (Drug)
5
干预措施: capecitabine [Xeloda] (Drug)
5
干预措施: trastuzumab [Herceptin] (Drug)
6
干预措施: RG1507 (Drug)
6
干预措施: sorafenib (Drug)
7
干预措施: RG1507 (Drug)
7
干预措施: bevacizumab [Avastin] (Drug)
8
干预措施: RG1507 (Drug)
8
干预措施: cetuximab (Drug)
8
干预措施: irinotecan (Drug)
9
干预措施: RG1507 (Drug)
9
干预措施: bevacizumab [Avastin] (Drug)
9
干预措施: carboplatin (Drug)
9
干预措施: paclitaxel (Drug)
结局指标
主要结局
Adverse events, laboratory parameters, vital signs
时间窗: Throughout study
次要结局
- Trough levels of R1507(Throughout study)