Clinical Trials /

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

NCT01682213

Description:

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

Related Conditions:
  • Melanoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 12-124
  • NCT ID: NCT01682213

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
Dabrafenibdabrafenib

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
dabrafenibExperimentalThis 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.
  • Dabrafenib

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:16 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants With Relapse Free Survival
Time Frame:24 months
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:2 years
Safety Issue:
Description:Overall survival is defined as the time from surgical resection to death or last follow-up.
Measure:Number of Participants With Adverse Events
Time Frame:1 year
Safety Issue:
Description:Toxicity will be graded by the NCI Common Toxicity Criteria (CTC) version 4.0 with each cycle of adjuvant dabrafenib.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Dabrafenib
  • (GSK2118436)
  • BRAFV600E/K
  • Resected AJCC Stage IIIC
  • 12-124

Last Updated

May 26, 2020