A Phase I, Open-Label Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety Profile of CC-4047 in Subjects With Advanced Solid Tumors
- Determine the maximum tolerated dose of CC-4047 in patients with advanced refractory
- Assess the safety of this drug in these patients.
- Assess the antitumor activity of this drug in these patients.
- Determine the effect of this drug on fetal hemoglobin levels in these patients.
OUTLINE: This is a open-label, uncontrolled, nonrandomized, dose-escalation, multicenter
- Treatment phase (course 1): Patients receive oral CC-4047 once daily on days 1-21
followed by a 7-day recovery period.
Cohorts of 3-6 patients receive escalating doses of CC-4047 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity (DLT).
Patients with no clinical evidence of progressive disease or DLT after course 1 continue
study treatment during the extension phase. Patients who develop a DLT during course 1 may
continue study treatment at the discretion of the investigator.
- Extension phase: Patients continue taking CC-4047 at their assigned cohort dose as in
course 1. Patients who tolerate a treatment-phase dose higher than the MTD continue
treatment at the MTD. Courses repeat every 28 days for up to 24 months in the absence
of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline and periodically during study to evaluate
fetal hemoglobin levels.
After completion of study treatment, patients are followed at 28 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
To determine the maximum tolerated dose (MTD) of daily CC-4047 in an initial 28-day cycle (21 days of CC-4047 followed by 7 days of no therapy) in subjects with advanced solid tumors (Cohort A).
after initial 28 day cycle
Matthew M. Cooney, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|