drugset / Trial / NCT01428492
Ph 1b Study to Evaluate GSK2110183 in Combination With Bortezomib and Dexamethasone in Subjects With Multiple Myeloma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one line of systemic treatment. Part 1 will identify the maximum tolerated dose(s) (MTD) of the combination regimen. Schedule A - GSK2110183 administered once daily with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) given biweekly. Part 2 will further explore the safety, tolerability and clinical activity of the MTD(s) identified in Part 1, including a pharmacokinetic cohort.
Timeline
- Start
- 2011-12
- Primary completion
- 2015-10
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afuresertib | Small molecule | 75 mg | Oral |
| Subject | Afuresertib | Small molecule | 100 mg | Oral |
| Subject | Afuresertib | Small molecule | 125 mg | Oral |
| Subject | Afuresertib | Small molecule | 150 mg | Oral |
| Subject | Bortezomib | Small molecule | 1 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.5 mg/m2 | — |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |