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

Adjuvant <span class="go-doc-concept go-doc-intervention">Dabrafenib</span> (<span class="go-doc-concept go-doc-intervention">GSK2118436</span>) in Patients With Surgically Resected AJCC Stage IIIC <span class="go-doc-concept go-doc-disease">Melanoma</span> Characterized by a <span class="go-doc-concept go-doc-biomarker">BRAFV600E</span>/K <span class="go-doc-concept go-doc-keyword">Mutation</span>

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

    NCT ID: NCT01682213

    ORG ID: 12-124

    Trial Conditions

    Melanoma

    Trial Interventions

    Drug Synonyms Arms
    Dabrafenib dabrafenib

    Trial Purpose

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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    dabrafenib Experimental 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. 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.

    Minimum Eligible Age: 16 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    determine the Relapse free survival

    Secondary Outcome Measures

    Overall survival

    assess toxicity

    Trial Keywords

    Dabrafenib

    (GSK2118436)

    BRAFV600E/K

    Resected AJCC Stage IIIC

    12-124