Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482521
Status:
COMPLETED
Last Update Posted:
2012-08-28
First Post:
2007-06-04
Brief Title:
CC-4047 in Treating Patients With Advanced Solid Tumors That Did Not Respond to Treatment
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
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
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE4Y06 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |