NCT02101008|CompletedPhase 2ResultsDMC
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Sponsor study identifier
interventional
12
0 countries
N/A
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
November 27, 2013
Actual (reported)Primary Objectives Determine the response rate associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc. Secondary Objectives Determine the progression-free survival associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc. Determine the overall survival associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc. Determine the toxicity associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc Determine the effect of disulfiram and chelated zinc on in vivo protein S-glutathionylation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 27, 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
February 2013
Actual (reported)November 27, 2013
Actual (reported)March 10, 2014
Actual (reported)April 1, 2014
Actual (reported)January 28, 2016
Actual (reported)Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Response to treatment will be measured by RECIST evaluation at disease assessment time-points from date of randomization until the date of first documented progression or death from any cause whichever came first (up to 15 months.)
Progression Free Survival
Every 56 days - for up to two years
There is only one arm. All patients are treated wtih disulfiram and chelated zinc.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
12 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2014
First Posted
April 1, 2014
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
Contact the study team to confirm eligibility.
Primary Completion
February 2013
Actual (reported)Study Completion
November 27, 2013
Actual (reported)Last Updated
December 13, 2023
Results First Posted
January 28, 2016
Record last verified: 2023-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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