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

Phase 2
18 Years
Open (Enrolling)
Recurrent Nasopharyngeal Carcinoma

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Trial Information

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Brigette Ma, MD, FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong


Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:




Start Date:

July 2011

Completion Date:

May 2014

Related Keywords:

  • Recurrent Nasopharyngeal Carcinoma
  • Carcinoma
  • Nasopharyngeal Neoplasms