MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma
Completed · Phase 2
Conditions studied: Recurrent Melanoma, Stage III Skin Melanoma, Stage IV Skin Melanoma
In brief
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.
Key facts
- Study ID
- NCT00866177
- Run by
- National Cancer Institute (NCI)
- People needed
- 167
- Starts
- 2009-03-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2015-08-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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