Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119249
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2005-07-12
Brief Title:
Sorafenib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of BAY 43-9006 NSC 724772 in Unresectable Stage III and IV Melanoma IND 69869
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:
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor This phase II trial is studying how well sorafenib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of sorafenib in terms of anti-tumor effects and proportion of clinical responses in patients with previously untreated unresectable stage III or stage IV melanoma
SECONDARY OBJECTIVES
I Correlate the efficacy of this drug with the presence of mutant or wild-type BRAF gene in tumors of these patients
II Determine the toxicity profile of this drug in these patients III Correlate serum cryptic collagen epitopes with the extent of tumor burden invasion and metastasis in patients treated with this drug
IV Determine the potential of serum cryptic collagen epitopes to serve as a surrogate marker for monitoring the course of disease in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to presence of BRAF gene mutation in tumor sample yes vs no
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 annually
PROJECTED ACCRUAL A total of 26-74 patients 13-37 per stratum will be accrued for this study within 52-185 months
I Determine the efficacy of sorafenib in terms of anti-tumor effects and proportion of clinical responses in patients with previously untreated unresectable stage III or stage IV melanoma
SECONDARY OBJECTIVES
I Correlate the efficacy of this drug with the presence of mutant or wild-type BRAF gene in tumors of these patients
II Determine the toxicity profile of this drug in these patients III Correlate serum cryptic collagen epitopes with the extent of tumor burden invasion and metastasis in patients treated with this drug
IV Determine the potential of serum cryptic collagen epitopes to serve as a surrogate marker for monitoring the course of disease in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to presence of BRAF gene mutation in tumor sample yes vs no
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 annually
PROJECTED ACCRUAL A total of 26-74 patients 13-37 per stratum will be accrued for this study within 52-185 months
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 |
|---|---|---|---|
| NYWCCC-NYU-0438 | None | None | None |
| N01CM62204 | NIH | None | None |
| CDR0000434613 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62204 |