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MK-2206 in Recurrent Nasopharyngeal Carcinoma (MC1079)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370070
First Posted: June 9, 2011
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
  Purpose
To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)

Condition Intervention Phase
Recurrent Nasopharyngeal Carcinoma Drug: MK-2206 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by CCTU, Chinese University of Hong Kong:

Primary Outcome Measures:
  • The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint [ Time Frame: 3 years ]

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

Enrollment: 12
Study Start Date: July 2011
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-2206 Drug: MK-2206
200mg weekly repeated q 28 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370070


Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CCTU, Comprehensive Cancer Trial Units, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01370070     History of Changes
Other Study ID Numbers: NPC024
First Submitted: May 12, 2011
First Posted: June 9, 2011
Last Update Posted: January 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases