Recurrent Nasopharyngeal Carcinoma
Conditions
Brief summary
To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)
Interventions
DRUGMK-2206
200mg weekly repeated q 28 days
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
| Progression-free survival | 3 Years |
| RECIST-based subjective response | 3 Years |
| Adverse events | 2 Years |
| treatment tolerability | 2 years |
| duration of response | 3 years |
| Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life | 3 years |
Countries
Hong Kong
Outcome results
None listed