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Tracking Information | |||||||||
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First Received Date † | May 30, 2007 | ||||||||
Last Updated Date | February 4, 2009 | ||||||||
Start Date † | May 2007 | ||||||||
Current Primary Outcome Measures † | |||||||||
Original Primary Outcome Measures † | |||||||||
Change History | Complete list of historical versions of study NCT00483301 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma | ||||||||
Official Title † | A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma | ||||||||
Brief Summary | The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma. |
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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 patients/institution is expected. Therefore, to reach the first stage, the study will take 1.2 to 1.8 years with one institution, 0.6 to 0.9 years with 2 institutions, and 0.4 to 0.6 years with 3. If the study continues to full accrual to 43 patients, completion will take 2.9 to 4.3 years with one institution, 1.4 to 2.2 years with two and 0.96 to 1.43 years with three institutions. |
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
Condition † | Malignant Melanoma | ||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 43 | ||||||||
Estimated Completion Date | May 2009 | ||||||||
Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00483301 | ||||||||
Responsible Party | Jose Lutzky, M.D., Mt. Sinai Medical Center | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Mt. Sinai Medical Center, Miami | ||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | Mt. Sinai Medical Center, Miami | ||||||||
Verification Date | February 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |