NCT00482521

CC-4047 in Treating Patients With Advanced Solid Tumors That Did Not Respond to Treatment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: CC-4047 may stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of CC-4047 in treating patients with advanced solid tumors that did not respond to treatment.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose of CC-4047 in patients with advanced refractory solid tumors. Secondary * 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 study. * 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	CC-4047	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.

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-09-01
• Completion: 2012-08-01
• First posted: 2007-06-05
• Last updated: 2012-08-28

Locations

2 sites across 1 country: United States