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Proteolix Initiates Dosing in Phase Ib Myeloma Trial

July 11, 2008

Proteolix has started patient dosing in a Phase Ib clinical trial to evaluate the safety and efficacy of Proteolix’s lead anticancer agent, carfilzomib, in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma.

The Phase Ib clinical trial is designed to evaluate safety and to establish a maximum-tolerated dose of carfilzomib in combination with lenalidomide and dexamethasone on a 28 day treatment cycle. Lenalidomide in combination with dexamethasone is indicated for use in patients with multiple myeloma who have had at least one prior therapy.

Patients will be divided into four cohorts and will receive escalating doses of carfilzomib and lenalidomide, combined with a set dose of dexamethasone. A secondary endpoint for the trial is overall response rate at four months.

In addition to the Phase Ib clinical trial, Proteolix is currently evaluating carfilzomib as a single agent for the treatment of multiple myeloma in two Phase II clinical trials.

Lori Kunkel, chief medical officer of Proteolix: “Initiating our first combination trial of carfilzomib complements our multi-pronged strategy to thoroughly explore carfilzomib’s potential in the treatment of patients with multiple myeloma for whom treatment options may be limited.”




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