NCT01370070

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

5.4 years

First QC Date

May 12, 2011

Last Update Submit

January 11, 2017

Conditions

Recurrent Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Adverse events

    2 Years

  • Overall survival

    3 years

  • Progression-free survival

    3 Years

  • RECIST-based subjective response

    3 Years

  • Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life

    3 years

  • +2 more secondary outcomes

Study Arms (1)

MK-2206

EXPERIMENTAL
Drug: MK-2206

Interventions

MK-2206DRUG

200mg weekly repeated q 28 days

MK-2206

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 26084990DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

MK 2206

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Brigette Ma, MD, FRACP

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comprehensive Cancer Trial Units

Study Record Dates

First Submitted

May 12, 2011

First Posted

June 9, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

HK(1)