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drugset / Trial / NCT01672736

A Trial of ASP7487 (OSI-906) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma

NCT01672736 ↗

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

Outcome

Outcome not reported

Stopped: “The Sponsor decided to stop further manufacture the study drug 'Linsitinib' in Nov 2015.”

Drugs

EvaluationDrugModalityDoseRoute
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 —

Indications

plasma cell myeloma