MK-2206 in Recurrent Nasopharyngeal Carcinoma

Recurrent Nasopharyngeal Carcinoma Clinical Trial

— MC1079  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370070
• Other study ID #: NPC024
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2011
• Last updated: January 11, 2017
• Start date: July 2011
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Neoplasms
• Recurrent Nasopharyngeal Carcinoma

Intervention

Drug:
• MK-2206
200mg weekly repeated q 28 days

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint		3 years	No
Secondary	Adverse events		2 Years	Yes
Secondary	Overall survival		3 years	No
Secondary	Progression-free survival		3 Years	No
Secondary	RECIST-based subjective response		3 Years	No
Secondary	Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life		3 years	No
Secondary	treatment tolerability		2 years	No
Secondary	duration of response		3 years	No