Clinical trial NCT01370070: MK-2206 in Recurrent Nasopharyngeal Carcinoma
Official title: Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Nasopharyngeal Carcinoma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint
timeFrame: 3 years
Secondary outcomes:
measure: Adverse events
timeFrame: 2 Years
measure: Overall survival
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 Years
measure: RECIST-based subjective response
timeFrame: 3 Years
measure: Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life
timeFrame: 3 years
measure: treatment tolerability
timeFrame: 2 years
measure: duration of response
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Brigette Ma, MD, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma BB, Goh BC, Lim WT, Hui EP, Tan EH, Lopes Gde L, Lo KW, Li L, Loong H, Foster NR, Erlichman C, King AD, Kam MK, Leung SF, Chan KC, Chan AT. Multicenter phase II study of the AKT inhibitor MK-2206 in recurrent or metastatic nasopharyngeal carcinoma from patients in the mayo phase II consortium and the cancer therapeutics research group (MC1079). Invest New Drugs. 2015 Aug;33(4):985-91. doi: 10.1007/s10637-015-0264-0. Epub 2015 Jun 19.