Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
National Comprehensive Cancer Network
GlaxoSmithKline
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01682213
First received: September 6, 2012
Last updated: March 5, 2014
Last verified: March 2014

September 6, 2012
March 5, 2014
September 2012
September 2014   (final data collection date for primary outcome measure)
determine the Relapse free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Relapse free survival is defined as the time from the initiation of adjuvant dabrafenib to the first recurrence or death as assessed by physical examination and radiographic evaluation. All recurrences will be confirmed by biopsy and histologic evaluation.
Same as current
Complete list of historical versions of study NCT01682213 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from the initiation of adjuvant dabrafenib to death or last follow-up.
  • assess toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Toxicity will be graded by the NCI Common Toxicity Criteria (CTC) version 4.0 with each cycle of adjuvant dabrafenib.
Same as current
Not Provided
Not Provided
 
Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation
A Phase 2 Trial of Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation

In this study, the investigator's want to find out if dabrafenib can stop stage IIIC melanoma from coming back after surgery.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Drug: Dabrafenib
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.
Experimental: dabrafenib
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.
Intervention: Drug: Dabrafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
23
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • AJCC (2009) stage IIIC cutaneous melanoma rendered free of disease by surgical resection no greater than 90 days prior study enrollment. Patients with unknown primaries will be eligible for this trial. Patients with a history of resected stage I or II cutaneous melanoma who subsequently have their first disease recurrence meeting the criteria for stage IIIC disease will also be eligible for this trial.
  • Patients must have clear margins after wide local excision. Patients with nodes that are palpable or detectable on radiologic imaging must have an adequate lymphadenectomy.
  • Patients must be adequately recovered from surgery, radiation therapy, or any surgical complications prior to enrollment. In general, this means patients will be off antibiotics from wound infections and drains removed. However, if necessary, patients can be treated with a drain in place at the discretion of the PI if the 90 days window is about to expire.
  • Histologic proof of melanoma reviewed and confirmed by MSKCC.
  • A documented BRAFV600E or BRAFV600K mutation by genotyping or IHC [35]performed by a CLIA certified laboratory.
  • Age ≥ 16 years old
  • ECOG performance status = 0 or Karnofsky Performance Status equivalent
  • The ability to swallow pills.
  • Patients must have adequate organ and marrow function as defined below:

Absolute neutrophil count ≥1.5 K/mcL Platelets ≥ 100 K/mcL Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)

≤ 3.0 X institutional ULN if the patient has Gilbert's Syndrome AST (SGOT) and ALT (SGPT) ≤ 2.5 X institutional ULN Creatinine ≤ 1.5 X institutional ULN or creatinine clearance (calculated or measured) > 60 ml/min

  • Women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of contraception.

Exclusion Criteria:

  • Patients with a history of stage III melanoma (any primary melanoma with locoregional nodal/subcutaneous disease) treated with surgical resection who subsequently have disease recurrence meeting the criteria for stage IIIC disease.
  • Prior therapy with ipilimumab, other BRAF inhibitors, or MEK inhibitors.
  • Concurrent adjuvant immunotherapy, chemotherapy, or radiotherapy.
  • Current use of a prohibited medication while on dabrafenib
  • Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
  • A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Pregnant women and lactating women.
  • A concurrent second malignancy even if it does not require active therapy. Patients with indolent B-cell malignancies will not be eligible. Prior malignancy will be allowed as long as the patient is known to be free of disease for at least 3 years.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • QTc interval > 500 msec unless a bundle branch block is also present.
Both
16 Years and older
No
Contact: Paul Chapman, MD 646-888-4162
Contact: Jedd Wolchok, MD PhD 646-888-2395
United States
 
NCT01682213
12-124
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • National Comprehensive Cancer Network
  • GlaxoSmithKline
Principal Investigator: Paul Chapman, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP