Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 5:35 PM
Study NCT ID:
NCT01217450
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2010-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 1 Study of AZD6244 in Combination With Cetuximab in Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-12
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 I trial is studying the side effects and the best dose of MEK Inhibitor AZD6244 when given together with cetuximab in patients with advanced or refractory solid tumors that cannot be removed by surgery. MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving MEK Inhibitor AZD6244 together with cetuximab may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the dose limiting toxicities and the maximum tolerated dose of AZD6244 in combination with cetuximab in advanced, refractory solid tumors.
II. To assess for evidence of anti-tumor activity with this combination, per tumor measurements using RECIST criteria.
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of AZD6244 and cetuximab when administered concomitantly.
II. To evaluate the safety and tolerability of the combination of AZD6244 and cetuximab in patients with K-RAS mutated metastatic colorectal cancer.
TERTIARY OBJECTIVES:
I. To assess the inhibition of the RAF/MEK/ERK pathway in peripheral blood mononuclear cells secondary to treatment with AZD6244.
II. To evaluate the pharmacokinetics of AZD6244 in combination with cetuximab and the relation to treatment side effects.
OUTLINE: This is a dose-escalation study of MEK inhibitor AZD6244.
Patients receive oral MEK inhibitor AZD6244 once or twice daily on days 1-28 and cetuximab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for pharmacokinetic and biomarker analyses.
After completion of study treatment, patients are followed up for 1 month or every 3 months for 1 year.
I. To determine the dose limiting toxicities and the maximum tolerated dose of AZD6244 in combination with cetuximab in advanced, refractory solid tumors.
II. To assess for evidence of anti-tumor activity with this combination, per tumor measurements using RECIST criteria.
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of AZD6244 and cetuximab when administered concomitantly.
II. To evaluate the safety and tolerability of the combination of AZD6244 and cetuximab in patients with K-RAS mutated metastatic colorectal cancer.
TERTIARY OBJECTIVES:
I. To assess the inhibition of the RAF/MEK/ERK pathway in peripheral blood mononuclear cells secondary to treatment with AZD6244.
II. To evaluate the pharmacokinetics of AZD6244 in combination with cetuximab and the relation to treatment side effects.
OUTLINE: This is a dose-escalation study of MEK inhibitor AZD6244.
Patients receive oral MEK inhibitor AZD6244 once or twice daily on days 1-28 and cetuximab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for pharmacokinetic and biomarker analyses.
After completion of study treatment, patients are followed up for 1 month or every 3 months for 1 year.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-02915 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000686619 | None | None | View | |
| CO10901 | OTHER | University of Wisconsin Medical School | View | |
| 8627 | OTHER | CTEP | View | |
| P30CA014520 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062491 | NIH | None | https://reporter.nih.gov/quic… | View |