drugset / Trial / NCT00982865
Trial of MSC1936369B in Subjects With Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a first in man trial with a primary objective being the determination of the Maximum Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors to see how safe is treatment with MSC1936369B.
Timeline
- Start
- 2007-12-31
- Primary completion
- 2013-03-31
- Completion
- 2016-04-30
Publications
- Lebbe C, Italiano A, Houede N, Awada A, Aftimos P, Lesimple T, Dinulescu M, Schellens JHM, Leijen S, Rottey S, Kruse V, Kefford R, Raymond E, Faivre S, Pages C, Gomez-Roca C, Schueler A, Goodstal S, Massimini G, Delord JP. Selective Oral MEK1/2 Inhibitor Pimasertib in Metastatic Melanoma: Antitumor Activity in a Phase I, Dose-Escalation Trial. Target Oncol. 2021 Jan;16(1):47-57. doi: 10.1007/s11523-020-00767-1.
- Delord JP, Italiano A, Awada A, Aftimos P, Houede N, Lebbe C, Pages C, Lesimple T, Dinulescu M, Schellens JHM, Leijen S, Rottey S, Kruse V, Kefford R, Faivre S, Gomez-Roca C, Scheuler A, Massimini G, Raymond E. Selective Oral MEK1/2 Inhibitor Pimasertib: A Phase I Trial in Patients with Advanced Solid Tumors. Target Oncol. 2021 Jan;16(1):37-46. doi: 10.1007/s11523-020-00768-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pimasertib | Small molecule | 1 mg | — |
| Subject | Pimasertib | Small molecule | 45 mg | — |
| Subject | Pimasertib | Small molecule | 60 mg | — |
| Subject | Pimasertib | Small molecule | 75 mg | — |
| Subject | Pimasertib | Small molecule | 90 mg | — |
| Subject | Pimasertib | Small molecule | 120 mg | — |
| Subject | Pimasertib | Small molecule | 150 mg | — |
| Subject | Pimasertib | Small molecule | 255 mg | — |