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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2019-11-01
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.
Conditions
Interventions
- DRUG
-
Amrubicin
40mg/m\^2 5 minute IV infusion for 3 consecutive days (21 day cycle)
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Markus Renschler, MD · Celgene Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-01
- Primary Completion
- 2011-05-01
- Completion
- 2011-05-01
Countries
- United States
Study Locations
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