Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483301
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
2007-05-30
Brief Title:
A Phase II Trial OF Carboplatin ABI-007 Abraxane And Sorafenib BAY 43-9006 in Metastatic Melanoma
Sponsor:
Mt Sinai Medical Center Miami
Organization:
Mt Sinai Medical Center Miami
Study Overview
Official Title:
A Phase II Trial OF Carboplatin ABI-007 Abraxane And Sorafenib BAY 43-9006 in Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2012-05
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:
The purpose of this study is to compare the effects good andor bad of Carboplatin and ABI-007 Abraxane in combination with Sorafenib BAY 43-9006 on Melanoma
Detailed Description:
The primary objective of this phase II multicenter trial is to
Measure the response rate RR of this combination and schedule in patients with metastatic melanoma
The secondary objectives are to
Assess the safety and toxicity of this regimen in this patient population
Determine the 1-year and median PFS of patients treated according to protocol
Determine overall survival OS
STUDY DESIGN
This will be a Phase II study single arm study with a two-stage design with a maximum sample size of 43 patients 18 in the first stage and 25 in the second stage
Study duration A minimum yearly accrual of 10-15 patientsinstitution is expected Therefore to reach the first stage the study will take 12 to 18 years with one institution 06 to 09 years with 2 institutions and 04 to 06 years with 3 If the study continues to full accrual to 43 patients completion will take 29 to 43 years with one institution 14 to 22 years with two and 096 to 143 years with three institutions
Measure the response rate RR of this combination and schedule in patients with metastatic melanoma
The secondary objectives are to
Assess the safety and toxicity of this regimen in this patient population
Determine the 1-year and median PFS of patients treated according to protocol
Determine overall survival OS
STUDY DESIGN
This will be a Phase II study single arm study with a two-stage design with a maximum sample size of 43 patients 18 in the first stage and 25 in the second stage
Study duration A minimum yearly accrual of 10-15 patientsinstitution is expected Therefore to reach the first stage the study will take 12 to 18 years with one institution 06 to 09 years with 2 institutions and 04 to 06 years with 3 If the study continues to full accrual to 43 patients completion will take 29 to 43 years with one institution 14 to 22 years with two and 096 to 143 years with three institutions
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