Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation
|ClinicalTrials.gov Identifier: NCT01682213|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2012
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Dabrafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation.
Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days.
- determine the Relapse free survival [ Time Frame: 1 year ]Relapse free survival is defined as the time from surgical resection to the first recurrence or death as assessed by physical examination and radiographic evaluation. All recurrences will be confirmed by biopsy and histologic evaluation.
- Overall survival [ Time Frame: 1 year ]Overall survival is defined as the time from surgical resection to death or last follow-up.
- assess toxicity [ Time Frame: 1 year ]Toxicity will be graded by the NCI Common Toxicity Criteria (CTC) version 4.0 with each cycle of adjuvant dabrafenib.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682213
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Paul Chapman, MD||Memorial Sloan Kettering Cancer Center|