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

Phase 1

Terminated

• Conditions: Multiple Myeloma
• Interventions: Drug: ASP7487, Velcade, Dexamethasone

• Registration Number: NCT01672736
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

The Phase 1 portion of the study will determine the MTD and DLTs of bortezomib administered on days 1, 4, 8 and 11 of a 21-day cycle combined with ASP7487 (OSI-906) dosed twice daily orally continuously. The combination of ASP7487 (OSI-906) with bortezomib has not previously been tested. The active agent bortezomib will be used during Cycle 1 - 8 at the recommended treatment dose of 1.3 mg/m2 days 1, 4, 8 and 11 and Cycles 9+ on days 1, 8, 15 and 22 of a 5-week cycle and ASP7487 (OSI-906) will be dose escalated form 75 mg to 150mg utilizing 3+3 design

Study Timeline

• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Study Start: 2012-09
• Primary Completion: 2017-03-27
• Study Completion: 2017-12-27
• Results First Submitted: 2018-03-15
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-12
• Last Update Submitted: 2018-09-12
• Results First Posted: 2018-09-13
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASP7487, Velcade, Dexamethasone	ASP7487, Velcade, Dexamethasone	ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose of the Combination of ASP7487 (OSI-906) With Velcade and Dexamethasone	45 months	* Phase 1: To determine the maximum tolerated dose (MTD) of ASP7487 (OSI-906) administered in combination with the recommended dose and schedule of bortezomib and dexamethasone; * Phase 2: To evaluate the antitumor activity of ASP7487 (OSI-906) in combination with bortezomib and dexamethasone at the MTD established from the Phase 1 component.

Trial Locations

Locations (6)

Emory University Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

University Of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

Sir Mortimer B. Davis-Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Queen Elizabeth II Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

University Health Network-Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada