Ignite Creation Date:
2024-05-05 @ 9:20 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00866177
Status:
COMPLETED
Last Update Posted:
2015-08-11
First Post:
2009-03-19
Brief Title:
MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Hyd-sulfate AZD6244 NSC 748727 in Patients With BRAF or NRAS Mutated Melanomas
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
PRIMARY OBJECTIVES
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
SECONDARY OBJECTIVES
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
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
SECONDARY OBJECTIVES
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA008748 | NIH | CTEP | httpsreporternihgovquickSearchP30CA008748 |
| NCI-2009-01164 | REGISTRY | None | None |
| MSKCC-09003 | None | None | None |
| CDR0000637669 | None | None | None |
| 09-003 | OTHER | None | None |
| 8252 | OTHER | None | None |
| N01CM62206 | NIH | None | None |