drugset / Trial / NCT01672736
A Trial of ASP7487 (OSI-906) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma
Phase 1/2
Terminated
19 enrolled
University Health Network, Toronto
Astellas Pharma Inc · collabMultiple Myeloma Research Consortium · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multi-center, open-label, non-randomized study. Patients will receive ASP7487 (OSI-906) in combination with bortezomib and dexamethasone. Phase 1 involves dose escalation of the combination, whereas Phase 2 involves the expansion of ASP7487 (OSI-906) combined with bortezomib and dexamethasone at the MTD to establish the ORR. This trial will accrue patients with relapsed or relapsed/refractory MM - a disease state for which bortezomib is approved to treat by the FDA and Health Canada. The combination of ASP7487 (OSI-906) with bortezomib is supported by pre-clinical work in MM in which the combination with an IGF1-R inhibitor enhances anti-tumor activity of bortezomib.
Timeline
- Start
- 2012-09
- Primary completion
- 2017-03-27
- Completion
- 2017-12-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | linsitinib | Small molecule | 75 mg | Oral |
| Subject | linsitinib | Small molecule | 100 mg | Oral |
| Subject | linsitinib | Small molecule | 150 mg | Oral |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | — |