MK-2206 in Recurrent Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)

Official Title
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Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma

Conditions
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Recurrent Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: MK-2206


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged > 18 year, able to give written informed consent. History of histologically or cytologically confirmed non-keratinizing NPC that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery. Patients must have progressed within 24 months of receiving one or two prior line of chemotherapy for recurrent disease, of which at least one line must contain platinum drugs such as Cisplatin, Carboplatin or oxaliplatin. Adequate organ reserve: neutrophils >1.5x109/L, platelets ≥100 x109/L, hemoglobin ≥9 g/dL, serum alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) or ALT< 5 x ULN in the presence of liver metastases, serum bilirubin < 2.5 x ULN, serum creatinine < 1.5 x ULN. Presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST ver 1.1). Exclusion Criteria: Chemotherapy, radiotherapy (except to bone metastases) or investigational treatment within 4 weeks of enrollment. Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled before the patient enters the trial. Cardiovascular: baseline QTcF > 450 msec (male) or QTcF >470 msec (female) Left bundle branch block, 2nd or 3rd degree AV block, bifascicular block, sick sinus syndrome, Wolff-Parkinson-white syndrome, significant sinus bradycardia (< 50bpm) . However, patients with asymptomatic right bundle branch block or 1st degree AV block, in the absence of known cardiac disease (e.g. coronary, valvular) are NOT excluded.. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-2206<br> | Drug: MK-2206<br>* 200mg weekly repeated q 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 2 Years | 
| Overall survival |  | 3 years | 
| Progression-free survival |  | 3 Years | 
| RECIST-based subjective response |  | 3 Years | 
| Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life |  | 3 years | 
| treatment tolerability |  | 2 years | 
| duration of response |  | 3 years |