drugset / Trial / NCT01023880

Study to Determine the Maximum Tolerated Dose and Evaluate the Efficacy and Safety of CEP-18770 (Delanzomib) in Patients With Relapsed Multiple Myeloma Refractory to the Most Recent Therapy

NCT01023880

Phase 1/2 Terminated 62 enrolled Cephalon
NaSingle-groupOpen-labelTreatment

Summary

The primary objective for part 1 of the study is to determine the maximum tolerated dose (MTD) of CEP-18770 in patients with relapsed and refractory multiple myeloma. The primary objective for part 2 is to evaluate the antitumor activity of CEP-18770 in patients treated at the MTD.

Timeline

Start
2010-01
Primary completion
2012-11
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject DELANZOMIB Small molecule 1.5 mg/m2 Intravenous
Subject DELANZOMIB Small molecule 2.1 mg/m2 Intravenous
Subject DELANZOMIB Small molecule 2.4 mg/m2 Intravenous

Indications