MK-2206 in Recurrent Nasopharyngeal Carcinoma (MC1079)

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

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

Study Overview

• Status: Completed
• Conditions: Recurrent Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: MK-2206

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-2206	Drug: MK-2206; 200mg weekly repeated q 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Brigette Ma, MD, FRACP, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Recurrence
• Other Study ID Numbers: NPC024