A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer
- Determine the maximum tolerated dose of CC-5013 in patients with refractory solid
tumors and/or lymphoma.
- Characterize the pharmacokinetic profile of this drug in these patients.
- Determine whether any correlations can be made between plasma concentrations of this
drug and toxicity or clinical activity or biological activity in these patients.
- Characterize the side effect profile of this drug in these patients.
- Determine the dose-limiting toxicity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral CC-5013 on day 1. Within 4-10 days, patients begin second course and
receive oral CC-5013 once daily on days 1-21. Subsequent courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 3-51 patients will be accrued for this study.
Primary Purpose: Treatment
William Dahut, MD
NCI - Medical Oncology Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|