drugset / Trial / NCT01378377
Combination Trial of Pimasertib (MSC1936369B) With Temsirolimus
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The research trial is testing the experimental drug pimasertib and the drug Torisel, given together, in the treatment of advanced solid tumors. The primary purpose of the study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of the drug combination.
Timeline
- Start
- 2011-05-27
- Primary completion
- 2012-02-23
- Completion
- 2012-02-23
Publications
- Mita M, Fu S, Piha-Paul SA, Janku F, Mita A, Natale R, Guo W, Zhao C, Kurzrock R, Naing A. Phase I trial of MEK 1/2 inhibitor pimasertib combined with mTOR inhibitor temsirolimus in patients with advanced solid tumors. Invest New Drugs. 2017 Oct;35(5):616-626. doi: 10.1007/s10637-017-0442-3. Epub 2017 Feb 13.
- Liu X, Lorusso P, Mita M, Piha-Paul S, Hong DS, Fu S, McQuinn L, Asatiani E, Doyle LA, Chen HX, Hess KR, Kurzrock R, Naing A. Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response. Oncologist. 2014 Apr;19(4):426-8. doi: 10.1634/theoncologist.2013-0231. Epub 2014 Mar 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pimasertib | Small molecule | 45 mg | Oral |
| Subject | Pimasertib | Small molecule | 75 mg | Oral |
| Subject | Temsirolimus | Small molecule | 12.5 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 25 mg | Intravenous |