Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00866177 |
RATIONALE: MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well MEK inhibitor AZD6244 works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: MEK inhibitor AZD6244 Genetic: gene expression analysis Genetic: mutation analysis Genetic: nucleic acid sequencing Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Hyd-Sulfate AZD6244 [NSC 741078] in Patients With V600E BRAF Mutated Melanomas |
Estimated Enrollment: | 40 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or
No active or untreated brain metastases
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( David Paul Kelsen ) |
Study ID Numbers: | CDR0000637669, MSKCC-09003 |
Study First Received: | March 19, 2009 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00866177 History of Changes |
Health Authority: | Unspecified |
stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |