Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031941
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2002-03-08
Brief Title:
CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Multidose Phase I Study of Oral CC5013 a Thalidomide Derivative in Patients With Refractory Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE CC-5013 may stop the growth of cancer by stopping blood flow to the tumor
PURPOSE Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors andor lymphoma that did not respond to previous therapy
PURPOSE Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors andor lymphoma that did not respond to previous therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of CC-5013 in patients with refractory solid tumors andor 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
Determine the maximum tolerated dose of CC-5013 in patients with refractory solid tumors andor 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
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 |
|---|---|---|---|
| CDR0000069241 | None | None | None |
| 02-C-0083 | None | None | None |