A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 12
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.
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
- •Subject must currently be participating in an Astellas sponsored linsitinib trial that has ended with respect to the overall study analysis.
- •Subject must not have met criteria for discontinuation or have progressed on the current linsitinib study in which they are participating.
- •Subject must be deriving benefit from continued treatment.
排除标准
- 未提供
研究组 & 干预措施
Arm D: High dose linsitinib BID plus weekly paclitaxel
Arm D includes subjects from Protocol OSI-906-202
干预措施: paclitaxel (Drug)
Arm C: High dose erlotinib monotherapy once daily
Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
干预措施: erlotinib (Drug)
Arm D: High dose linsitinib BID plus weekly paclitaxel
Arm D includes subjects from Protocol OSI-906-202
干预措施: linsitinib (Drug)
Arm A: High dose linsitinib twice daily monotherapy
Arm A includes subjects from Protocol OSI-906-301
干预措施: linsitinib (Drug)
Arm B: High dose linsitinib BID plus high dose erlotinib QD
Arm B includes subjects from Protocol OSI-906-205
干预措施: linsitinib (Drug)
Arm B: High dose linsitinib BID plus high dose erlotinib QD
Arm B includes subjects from Protocol OSI-906-205
干预措施: erlotinib (Drug)
Arm E: Highest dose linsitinib intermittent once daily
Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
干预措施: linsitinib (Drug)
Arm E: Highest dose linsitinib intermittent once daily
Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
干预措施: paclitaxel (Drug)
Arm F: Paclitaxel alone weekly
Arm F includes subjects from Protocol OSI-906-202
干预措施: paclitaxel (Drug)
Arm G: Lowest dose linsitinib twice daily + low dose erlotinib
Arm G includes subjects from Protocol OSI-906-103
干预措施: linsitinib (Drug)
Arm G: Lowest dose linsitinib twice daily + low dose erlotinib
Arm G includes subjects from Protocol OSI-906-103
干预措施: erlotinib (Drug)
Arm H: high dose linsitinib twice daily
includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)
干预措施: linsitinib (Drug)
Arm I: highest dose linsitinib once daily
includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17
干预措施: linsitinib (Drug)
Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: linsitinib (Drug)
Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: Bortezomib (Drug)
Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: Dexamethasone (Drug)
Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: linsitinib (Drug)
Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: Bortezomib (Drug)
Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: Dexamethasone (Drug)
Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: linsitinib (Drug)
Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: Bortezomib (Drug)
Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: 24 months
次要结局
未报告次要终点