MK-2206 in Recurrent Nasopharyngeal Carcinoma (MC1079)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01370070
First received: May 12, 2011
Last updated: May 21, 2014
Last verified: May 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • RECIST-based subjective response [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • treatment tolerability [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • duration of response [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-2206 Drug: MK-2206
200mg weekly repeated q 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: CCTU, Comprehensive Cancer Trial Units, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01370070     History of Changes
Other Study ID Numbers: NPC024
Study First Received: May 12, 2011
Last Updated: May 21, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 19, 2014