drugset / Trial / NCT02412722
A Safety, Tolerability, and Pharmacokinetics Study of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purposes of this study are to evaluate the safety and tolerability of sapanisertib (MLN0128) milled active pharmaceutical ingredient (API) capsules administered both as a single agent and in combination with paclitaxel, to characterize the effect of a high-fat meal on the pharmacokinetics (PK) of sapanisertib milled API capsules, and to characterize the PK of sapanisertib milled API capsules when administered on an empty stomach approximately 24 hours after paclitaxel infusion.
Timeline
- Start
- 2015-03-26
- Primary completion
- 2018-05-31
- Completion
- 2018-05-31
Publications
- Background Chopra M. Annual Congress of the European Society for Medical Oncology (ESMO): Copenhagen, Denmark; 7-11 October 2016. Target Oncol. 2016 Dec;11(6):705-709. doi: 10.1007/s11523-016-0464-3. No abstract available.
- Moore KN, Bauer TM, Falchook GS, Chowdhury S, Patel C, Neuwirth R, Enke A, Zohren F, Patel MR. Phase I study of the investigational oral mTORC1/2 inhibitor sapanisertib (TAK-228): tolerability and food effects of a milled formulation in patients with advanced solid tumours. ESMO Open. 2018 Feb 1;3(2):e000291. doi: 10.1136/esmoopen-2017-000291. eCollection 2018.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Sapanisertib | Small molecule | 3 mg | Oral |
| Subject | Sapanisertib | Small molecule | 4 mg | Oral |
| Subject | Sapanisertib | Small molecule | 6 mg | Oral |
| Subject | Sapanisertib | Small molecule | 20 mg | Oral |
| Subject | Sapanisertib | Small molecule | 30 mg | Oral |