Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131937
Status:
COMPLETED
Last Update Posted:
2015-09-03
First Post:
2005-08-16
Brief Title:
Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Sorafenib BAY 43-9006 in Recurrent Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-07
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 II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkins lymphoma 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 tumor
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the response rate of treatment with sorafenib BAY43-9006 in patients with recurrent aggressive non-Hodgkins lymphomas
SECONDARY OBJECTIVES
I To evaluate the duration of response and progression free survival of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkins Lymphomas
II To characterize the toxicity of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkins Lymphomas
III To further characterize the pharmacokinetics properties of BAY43-9006 and assess influence of monooxygenases polymorphisms and multi-drug resistance transporter MDR on pharmacokinetics
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 year
PLANNED ACCRUAL 41 ACTUAL ACCRUAL 14
I To evaluate the response rate of treatment with sorafenib BAY43-9006 in patients with recurrent aggressive non-Hodgkins lymphomas
SECONDARY OBJECTIVES
I To evaluate the duration of response and progression free survival of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkins Lymphomas
II To characterize the toxicity of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkins Lymphomas
III To further characterize the pharmacokinetics properties of BAY43-9006 and assess influence of monooxygenases polymorphisms and multi-drug resistance transporter MDR on pharmacokinetics
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 year
PLANNED ACCRUAL 41 ACTUAL ACCRUAL 14
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 |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group | httpsreporternihgovquickSearchU10CA021115 |
| E1404 | OTHER | None | None |