drugset / Trial / NCT00915083

A Phase I Study to Assess the Safety, Pharmacokinetics, and Potential Effects of Amrubicin on the QT/QTc Interval in Cancer Patients With Advanced Solid Tumors.

NCT00915083

Phase 1 Completed 24 enrolled Celgene Corporation
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to determine whether amrubicin is safe and effective in the treatment of patients with advanced solid tumors. The study will assess the pharmacokinetics of the amrubicin and if it has an effect on the heart.

Timeline

Start
2009-06-01
Primary completion
2011-05-01
Completion
2011-05-01

Publications

  • Background Chen N, et al. Phase I study to assess pharmacokinetics (PK), QT/QTc effect, and safety of amrubicin in patients (pts) with advanced solid tumors. Presented at 2011 ASCO Annual Meeting, June 3-7, 2011, Chicaco, IL. Abstract No. 7073 N

Drugs

EvaluationDrugModalityDoseRoute
Subject Amrubicin Small molecule 40 mg/m2 Intravenous

Indications