MK-2206 in Recurrent Nasopharyngeal Carcinoma
- Registration Number
- NCT01370070
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MK-2206 MK-2206 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method RECIST-based subjective response 3 Years Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life 3 years treatment tolerability 2 years Adverse events 2 Years Progression-free survival 3 Years Overall survival 3 years duration of response 3 years
Trial Locations
- Locations (1)
Department of Clinical Oncology, Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong