Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00888134
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2009-04-23
Brief Title:
Selumetinib in Cancers With BRAF Mutations
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Clinical Trial of the MEK 12 Inhibitor AZD6244 in Cancers With BRAF Mutations Identified by Prospective Genotypic Analysis
Status:
COMPLETED
Status Verified Date:
2015-07
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:
The purpose of this research study is to determine if selumetinib is safe and effective in treating patients with cancers with a mutated BRAF gene Selumetinib is an investigational drug that works by blocking a protein called MEK which is known to play a role in the growth of cancer cells lines and tumors that have a mutated BRAF gene There are multiple types of cancers that have mutations in the BRAF gene and depend on the activity of this gene for their growth and survival
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the objective response rate to AZD6244 selumetinib in patients with cancers other than melanoma in which BRAF mutations have been identified prospectively
SECONDARY OBJECTIVES
I To evaluate progression-free survival in subjects treated with AZD6244 II To obtain a preliminary estimate of the objective response rate in non-small cell lung cancers and colon cancers with BRAF mutations
III To explore biologic correlates of responsiveness to AZD6244 and specifically to correlate AKT pathway activity with sensitivity to MEK inhibition in the BRAF mutant class of tumors
IV To estimate the sensitivity and specificity of detection of the BRAF V600E mutation in circulating tumor cells CTC using a microfluidic platform the CTC-chip
OUTLINE
Patients receive selumetinib orally PO twice daily BID for 3 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year every 6 months for 1 year and then annually thereafter
I To evaluate the objective response rate to AZD6244 selumetinib in patients with cancers other than melanoma in which BRAF mutations have been identified prospectively
SECONDARY OBJECTIVES
I To evaluate progression-free survival in subjects treated with AZD6244 II To obtain a preliminary estimate of the objective response rate in non-small cell lung cancers and colon cancers with BRAF mutations
III To explore biologic correlates of responsiveness to AZD6244 and specifically to correlate AKT pathway activity with sensitivity to MEK inhibition in the BRAF mutant class of tumors
IV To estimate the sensitivity and specificity of detection of the BRAF V600E mutation in circulating tumor cells CTC using a microfluidic platform the CTC-chip
OUTLINE
Patients receive selumetinib orally PO twice daily BID for 3 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year every 6 months for 1 year and then annually thereafter
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 |
|---|---|---|---|
| NCI-2013-00576 | REGISTRY | None | None |
| U01CA062490 | NIH | None | None |
| P30CA006516 | NIH | None | None |
| CDR642346 | None | None | None |
| N01CM62206 | NIH | None | None |
| 09-005 | OTHER | None | None |
| 8281 | OTHER | CTEP | httpsreporternihgovquickSearchN01CM62206 |