Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Drug: Akt inhibitor MK2206
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma|
- Proportion of Patients Alive and Progression-free [ Time Frame: 6 months ] [ Designated as safety issue: No ]The primary endpoint of this trial is the proportion of patients alive and progression-free at 6 months. Progression status is evaluated using RECIST version 1.1. A Progression is defined as either: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (less than 1.0 cm short axis) and increased to greater than or equal to 1 cm short axis during follow up. Or, at least a 20% increase in sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes.
- Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
- Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. Only the severe or worse adverse events will be assessed, regardless of relationship to the study treatment.
- Overall Survival [ Time Frame: From registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Progression-free Survival [ Time Frame: From registration to the first of either death due to any cause or progression, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Akt inhibitor MK2206)
Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Akt inhibitor MK2206
Other Name: MK2206
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..
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349933
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|China, Hong Kong|
|Chinese University of Hong Kong-Prince of Wales Hospital|
|Shatin, Hong Kong, China, OX1 3UJ|
|Johns Hopkins Singapore International Medical Centre|
|Singapore, Singapore, 308433|
|National Cancer Centre|
|Singapore, Singapore, 169610|
|National University Hospital|
|Singapore, Singapore, 119074|
|Principal Investigator:||Brigette Ma||Mayo Clinic|