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2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT01349933
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2011-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-10
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 Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint..
SECONDARY OBJECTIVES:
I. To evaluate best response and duration of response for patients treated with MK2206 (Akt inhibitor MK2206).
II. To evaluate the overall survival and progression-free survival (PFS) of patients treated with MK2206.
III. To evaluate safety and tolerability of MK2206.
TERTIARY OBJECTIVES:
I. To evaluate the pharmacokinetics of MK2206 in Asian patients. II. To study the pharmacodynamic effect of MK2206 using biomarkers and correlation with cancer-related outcomes.
OUTLINE: This is a multicenter study.
Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for pharmacogenomic and pharmacokinetic studies.
After completion of study therapy, patients are followed up for up to 3 years.
I. To determine the proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint..
SECONDARY OBJECTIVES:
I. To evaluate best response and duration of response for patients treated with MK2206 (Akt inhibitor MK2206).
II. To evaluate the overall survival and progression-free survival (PFS) of patients treated with MK2206.
III. To evaluate safety and tolerability of MK2206.
TERTIARY OBJECTIVES:
I. To evaluate the pharmacokinetics of MK2206 in Asian patients. II. To study the pharmacodynamic effect of MK2206 using biomarkers and correlation with cancer-related outcomes.
OUTLINE: This is a multicenter study.
Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for pharmacogenomic and pharmacokinetic studies.
After completion of study therapy, patients are followed up for up to 3 years.
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-2011-02581 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000696863 | None | None | View | |
| MC1079 | OTHER | Mayo Clinic | View | |
| 8761 | OTHER | CTEP | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM00099 | NIH | None | https://reporter.nih.gov/quic… | View |