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Sponsors and Collaborators: |
Mt. Sinai Medical Center, Miami Abraxis BioScience Inc. Bayer |
Information provided by: | Mt. Sinai Medical Center, Miami |
ClinicalTrials.gov Identifier: | NCT00483301 |
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.
Condition | Intervention | Phase |
Malignant Melanoma |
Drug: Sorafenib (BAY 43-9006) Drug: ABI-007(Abraxane) |
Phase II |
MedlinePlus related topics: | Melanoma |
ChemIDplus related topics: | Carboplatin Paclitaxel Sorafenib Sorafenib tosylate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment |
Official Title: | A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jose Lutzky, MD | 305-535-3300 | jlutzky@aptiumoncology.com |
Contact: Yvonne E. Nunez | 305-535-3350 | yenrique@msmc.com |
United States, Florida | |||||
Mt. Sinai Medical Center | Recruiting | ||||
Miami Beach, Florida, United States, 33140 | |||||
Contact: Jose Lutzky, MD 305-535-3300 jlutzky@aptiumoncology.com | |||||
Contact: Yvonne E. Nunez 305-535-3350 yenrique@msmc.com | |||||
United States, Illinois | |||||
Jon Richards | Not yet recruiting | ||||
Park Ridge, Illinois, United States, 60068-1270 | |||||
Contact: Jon Richards, MD, PhD 847-268-8200 jrichards@oncmed.net | |||||
Sub-Investigator: Jon Richards, MD, PhD | |||||
United States, Minnesota | |||||
University of Minnesota Cancer Center | Not yet recruiting | ||||
Minneapolis, Minnesota, United States, 55455 | |||||
Contact: Arkadiusz Dudek, MD, PhD 612-624-0123 dudek002@umn.edu | |||||
Sub-Investigator: Arkadiusz Dudek, MD, PhD |
Mt. Sinai Medical Center, Miami |
Abraxis BioScience Inc. |
Bayer |
Principal Investigator: | Jose Lutzky, Physician | Mt. Sinai Medical Center Miami Beach Florida |
Study ID Numbers: | MEL0205 |
First Received: | May 30, 2007 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00483301 |
Health Authority: | United States: Institutional Review Board |
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