Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
The goal of this clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested.
详细描述
The Study Drug:
Temsirolimus is designed to block the growth of cancer cells, which may cause the cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive temsirolimus through a needle in your vein on Days 1, 8, 15, and 22 of each 4-week study cycle. On Day 1 of Cycle 1, the study drug will be given over 60 minutes. If you tolerate the study drug well on Day 1 of Cycle 1, it will be given over 30 minutes at all other scheduled administration dates as long as you still tolerate it well. If the dose is not well tolerated, the dose will be reduced for future study visits.
You will receive Benadryl (diphenhydramine) or a similar drug by vein to help prevent side effects about 30 minutes before you receive the study drug.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least 3 months (unless temsirolimus is indicated as standard treatment for that disease).
- •Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
- •Patients must have creatinine </= 3 X upper limit of normal (ULN); absolute neutrophil count >/= 1,000/mL; platelets >/= 50,000; bilirubin </= 3.0 gm/dL. Except for patients with liver metastases: total bilirubin </= 5 ULN.
- •Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study.
- •Patients must be off other anti-tumor agents for at least 5 half lives of the agent or 4 wks from the last day of treatment, whichever is shorter. For cytotoxic therapies, patients should be off treatment for 3 or more weeks.
- •Patients may not be receiving any other experimental agents that are not FDA approved.
- •Ability to understand and willingness to sign a written consent document.
- •Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus.
排除标准
- •Pregnant or lactating women.
- •Patients with creatinine clearance <10 mL/min
- •Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
- •Patients with major surgery within 30 days prior to entering study.
- •Patients on inhibitors or inducers of CYP3A4 metabolism will have the inhibitors or inducers stopped unless clinically contraindicated. See section 6 (Concomitant Medications) and Appendix E of the protocol for details.
研究组 & 干预措施
Temsirolimus
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
干预措施: Temsirolimus (Drug)
结局指标
主要结局
Tumor Response
时间窗: Baseline to Disease Progression (restaged at 8 weeks and at 4 months)
For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).
次要结局
未报告次要终点