Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278382
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2006-01-16
Brief Title:
Sorafenib in Treating Patients With Recurrent Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of BAY 43-9006 IND 69896 in Chemosensitive Relapsed Aggressive Non-Hodgkins Lymphomas
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkins lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the overall response rate including complete and partial responses in patients with chemosensitive relapsed aggressive non-Hodgkins lymphoma treated with sorafenib
SECONDARY OBJECTIVES
I Determine progression-free and overall survival of patients treated with this drug
II Determine response duration in patients treated with this drug
OUTLINE This is an open-label study
Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study
I Determine the overall response rate including complete and partial responses in patients with chemosensitive relapsed aggressive non-Hodgkins lymphoma treated with sorafenib
SECONDARY OBJECTIVES
I Determine progression-free and overall survival of patients treated with this drug
II Determine response duration in patients treated with this drug
OUTLINE This is an open-label study
Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 33 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 |
|---|---|---|---|
| GCC0508 | None | None | None |
| CDR0000456442 | REGISTRY | PDQ Physician Data Query | None |