This trial is active, not recruiting.

Condition recurrent nasopharyngeal carcinoma
Treatment mk-2206
Phase phase 2
Target AKT
Sponsor Chinese University of Hong Kong
Start date July 2011
End date December 2016
Trial size 12 participants
Trial identifier NCT01370070, NPC024


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
200mg weekly repeated q 28 days

Primary Outcomes

The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint
time frame: 3 years

Secondary Outcomes

Adverse events
time frame: 2 Years
Overall survival
time frame: 3 years
Progression-free survival
time frame: 3 Years
RECIST-based subjective response
time frame: 3 Years
Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life
time frame: 3 years
treatment tolerability
time frame: 2 years
duration of response
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
Principal investigator Brigette Ma, MD, FRACP
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Chinese University of Hong Kong.