drugset / Trial / NCT01394016
A Phase 1 Study of LY2835219 In Participants With Advanced Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine a safe dose of Abemaciclib to be given to participants with advanced cancer and to determine any side effects that may be associated with Abemaciclib in this population. Efficacy measures will be used to assess the activity of Abemaciclib in this population.
Timeline
- Start
- 2009-12-07
- Primary completion
- 2014-05-29
- Completion
- 2022-04-12
Publications
- Tate SC, Sykes AK, Kulanthaivel P, Chan EM, Turner PK, Cronier DM. A Population Pharmacokinetic and Pharmacodynamic Analysis of Abemaciclib in a Phase I Clinical Trial in Cancer Patients. Clin Pharmacokinet. 2018 Mar;57(3):335-344. doi: 10.1007/s40262-017-0559-8.
- Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 50 mg | Oral |
| Subject | Abemaciclib | Small molecule | 75 mg | Oral |
| Subject | Abemaciclib | Small molecule | 100 mg | Oral |
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Subject | Abemaciclib | Small molecule | 200 mg | Oral |
| Subject | Abemaciclib | Small molecule | 225 mg | Oral |
| Subject | Abemaciclib | Small molecule | 275 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
Indications
No indication recorded.