We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00866177
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well MEK inhibitor AZD6244 works in treating patients with stage III or stage IV melanoma. MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
Recurrent Melanoma Stage III Skin Melanoma Stage IV Skin Melanoma Other: Laboratory Biomarker Analysis Drug: Selumetinib Phase 2

Detailed Description:


I. Determine the response in patients with V600E or V600K BRAF-mutated or NRAS-mutated stage III or stage IV melanoma with low or high phospho-pAKT expression treated with MEK inhibitor AZD6244.


I. Identify other genetic predictors of sensitivity to MEK inhibition.

OUTLINE: Patients are stratified according to pAKT expression (low vs high).

Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected for correlative laboratory studies. Samples are assessed for expression of pAKT, pPRAS40, and PTEN by IHC and mutations in BRAF, NRAS, KIT, and PIK3CAP by MALDI-TOF. PTEN is sequenced in tumors using whole genome amplification followed by high-throughput bidirectional dideoxynucleotide sequencing of PCR-amplified gene products.

After completion of study treatment, patients are followed for 4 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Hyd-sulfate AZD6244 [NSC 748727] in Patients With BRAF or NRAS Mutated Melanomas
Study Start Date : March 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Selumetinib

Arm Intervention/treatment
Experimental: Arm I
Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Selumetinib
Given orally
Other Names:
  • ARRY-142886
  • AZD6244
  • MEK Inhibitor AZD6244

Primary Outcome Measures :
  1. Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST [ Time Frame: Up to 4 weeks ]
    Anti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed melanoma

    • Stage IV or stage III disease not potentially curable with surgery
  • Documented tumor progression
  • Must have a V600E or V600K BRAF-mutated tumor, or a NRAS mutation at condons 12, 13, or 61
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have tumor tissue (block or unstained slides) available for IHC studies
  • No primary uveal or mucosal melanoma
  • No active or untreated brain metastases

    • Treated brain metastases allowed provided they have been stable for ≥ 3 months
  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mcL
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Hemoglobin ≥ 9.0 g/dL (no requirement for transfusions within the past 2 weeks)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 16 weeks after completion of study treatment
  • No refractory nausea and vomiting, chronic gastrointestinal disease (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
  • No concurrent uncontrolled illness, including, but not limited to, any of the following:

    • Ongoing or active infection or bleeding
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situation that would limit compliance with study requirements
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to MEK inhibitor AZD6244
  • Any number of prior therapies allowed
  • At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 4 months since prior anti-CTLA4 monoclonal antibody therapy
  • At least 4 weeks since other prior systemic therapy
  • No other concurrent investigational agents
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent vitamin E supplementation or multivitamin supplements that provide a total daily dose in excess of 100% of the recommended daily dose of vitamin E
  • No concurrent anticancer chemotherapy or other systemic drugs
  • Concurrent palliative radiotherapy allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866177

Layout table for location information
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Paul Chapman Memorial Sloan Kettering Cancer Center
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00866177    
Other Study ID Numbers: NCI-2009-01164
NCI-2009-01164 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-003 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
8252 ( Other Identifier: CTEP )
N01CM62206 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2009    Key Record Dates
Results First Posted: August 11, 2015
Last Update Posted: August 11, 2015
Last Verified: June 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases