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