Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118170
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2005-07-08
Brief Title:
Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors Multiple Myeloma or Non-Hodgkins Lymphoma With or Without Impaired Liver or Kidney Function
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pharmacokinetic and Phase I Study of Sorafenib BAY 43-9006 NSC 724772 IND 69896 for Solid Tumors and Hematologic Malignancies in Patients With Hepatic or Renal Dysfunction
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase I trial is studying the side effects and best dose of sorafenib in treating patients with metastatic or unresectable solid tumors multiple myeloma or non-Hodgkins lymphoma with or without impaired liver or kidney function Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer Sorafenib may have different effects in patients who have changes in their liver or kidney function
Detailed Description:
PRIMARY OBJECTIVES
I To characterize the pharmacokinetics of BAY 43-9006 in patients with hepatic or renal dysfunction part 1 of the study
II To determine a tolerable starting dose of BAY 43-9006 in patients with varying degrees of hepatic or renal dysfunction part 2 of the study
OUTLINE This is a dose-escalation multicenter study Patients are assigned to 1 of 9 treatment cohorts according to hepatic or renal function
Patients receive oral sorafenib once on day 1 and then once daily twice daily or every other day beginning on day 8 and continuing for 3 months Patients are re-evaluated at 3 months Patients with responding disease may continue study treatment in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per treatment cohort receive escalating doses of sorafenib 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 At least 6 patients are treated at the MTD
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study
I To characterize the pharmacokinetics of BAY 43-9006 in patients with hepatic or renal dysfunction part 1 of the study
II To determine a tolerable starting dose of BAY 43-9006 in patients with varying degrees of hepatic or renal dysfunction part 2 of the study
OUTLINE This is a dose-escalation multicenter study Patients are assigned to 1 of 9 treatment cohorts according to hepatic or renal function
Patients receive oral sorafenib once on day 1 and then once daily twice daily or every other day beginning on day 8 and continuing for 3 months Patients are re-evaluated at 3 months Patients with responding disease may continue study treatment in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per treatment cohort receive escalating doses of sorafenib 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 At least 6 patients are treated at the MTD
PROJECTED ACCRUAL A total of 120 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 |
|---|---|---|---|
| CDR0000433342 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-60301 | None | None | None |
| U10CA031946 | NIH | None | None |