Brief Title
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
Brief Summary
To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic
nasopharyngeal carcinoma (NPC)
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint
Secondary Outcome
Adverse events
Condition
Recurrent Nasopharyngeal Carcinoma
Intervention
MK-2206
Study Arms / Comparison Groups
MK-2206
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
July 2011
Completion Date
January 2017
Primary Completion Date
December 2016
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Brigette Ma, MD, FRACP, ,
Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT01370070
Organization ID
NPC024
Responsible Party
Principal Investigator
Study Sponsor
Chinese University of Hong Kong
Study Sponsor
Brigette Ma, MD, FRACP, Principal Investigator, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Verification Date
January 2017