A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 5
- 主要终点
- Overall Response Rate
研究概览
简要总结
Study IPI-504-15 is a Phase 1b/2 clinical trial to evaluate the safety and efficacy of retaspimycin HCl (IPI-504) plus everolimus in patients with KRAS mutant Non-small Cell Lung Cancer (NSCLC).
详细描述
This is a Phase Ib/2 study of retaspimycin HCl (IPI-504) in combination with everolimus. The Phase 1b portion is to test the safety and tolerability of retaspimycin HCl (IPI-504) in combination with everolimus and determine the highest dose of retaspimycin HCl (IPI-504) and everolimus that can safely be given in combination. The Phase 2 portion of this study will continue the evaluation of safety of retaspimycin HCl (IPI-504) in combination with everolimus and compare the effect of the study drugs on tumor response and life expectancy in patients with KRAS mutant NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •≥18 years of age
- •Voluntarily sign an informed consent form (ICF).
- •Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV
- •Archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
- •Experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
- •ECOG performance of 0-1.
排除标准
- •Prior treatment with IPI-504 or other Hsp90 inhibitors.
- •Prior treatment with everolimus, other rapamycin analogs, AP23573(Ridaforolimus), rapamycin, or other mTOR inhibitors.
- •Has not recovered from any toxicities related to prior treatment (to Grade 1 or baseline), excluding alopecia.
- •Inadequate hematologic function defined as:
- •Inadequate hepatic function defined by:
- •Inadequate renal function defined by serum creatinine >1.5 x ULN.
研究组 & 干预措施
Retaspimycin HCl (IPI-504) and Everolimus
Retaspimycin HCl (IPI-504) and everolimus will be administered on a 21-day cycle. All patients will remain on study until progression of disease or intolerability to study treatments occurs.
干预措施: IPI-504 (Drug)
Retaspimycin HCl (IPI-504) and Everolimus
Retaspimycin HCl (IPI-504) and everolimus will be administered on a 21-day cycle. All patients will remain on study until progression of disease or intolerability to study treatments occurs.
干预措施: Everolimus (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to three years from last patient study visit
Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
次要结局
- Progression Free Survival(Up to three years from last patient study visit)
- Time to Progression(Up to three years from last patient study visit)
- Overall Survival(Up to three years from last patient study visit)