Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Completed · Phase 2

Conditions studied: Recurrent Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx

In brief

This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01349933

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2011-04-01

Expected to finish

2013-10-01

Last updated by the study team

2017-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery
• Measurable disease according to the RECIST criteria
• Progressed =< 24 months of receiving one or two prior line(s) of chemotherapy for recurrent disease, of which at least one line must contain platinum drugs such as cisplatin, carboplatin or oxaliplatin
• ECOG performance status 0, 1, or 2
• Hemoglobin >= 9 g/dL
• ANC >= 1,500/μL
• Platelet count >= 100,000/μL
• Total bilirubin =< 2.5 times upper limit of normal (ULN)
• ALT =< 2.5 times ULN (=< 5 times ULN for patients with liver metastases)
• Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m\^2
• Ability to understand and the willingness to sign a written informed consent document
• Willingness to donate blood for mandatory correlative research studies
• Negative (serum) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

You may not qualify if…

• Any of the following
• Chemotherapy =< 4 weeks prior to registration
• Radiotherapy =< 4 weeks prior to registration
• Nitrosoureas or Mitomycin C =< 4 weeks prior to registration
• Those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• NOTE: Prior palliative radiotherapy to bone metastases is allowed =< 4 weeks prior to registration
• Prior investigational agents =< 4 weeks prior to registration
• Symptomatic brain metastases; NOTE: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa(e) are not regarded as brain metastases and are not excluded
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study
• Prior potent and moderate inhibitors and inducers of CYP3A4 =< 2 weeks prior to registration:
• Drugs that are forbidden, potent inducers of CYP3A4: phenytoin, phenobarbitone, carbamazepine, barbiturate, rifampicin, St John's Wort.
• Drugs that significantly affect metabolizing activity by way of enzyme inhibition of CYP3A4: ketoconazole, itraconazole, fluconazole, indinavir, ritonavir, erythromycin, cimetidine, clarithromycin
• Unwillingness to go off other inducers and inhibitors of CYP3A4 during the first 2 cycles of MK-2206; NOTE: avoiding these drugs is critical during the first 2 cycles of MK-2206when blood samples are being taken for the correlative study unless there is an urgent medical need and alternatives are not available
• Poorly controlled diabetes mellitus or insulin controlled diabetes; NOTE: As a general guide, patients with a fasting glucose level > 150 mg/dL (HbA1c <8%, > 8.3 mmol/L), or a random glucose level of >180mg/dL (> 10 mmol/L) is considered to have inadequately controlled diabetes and are not eligible for this study; however, such patients can become eligible in the future if their fasting glucose levels improve with medical treatment
• QTc prolongation (defined as a QTc interval > 450 msec for males and >470 msec for females) or other significant ECG abnormalities; NOTE: patients with clinically significant cardiac conduction abnormalities should be excluded, these include left bundle branch block (LBBB), 2nd or 3rd degree AV block, bifascicular block, sick sinus syndrome, Wolff-Parkinson-white syndrome, sinus bradycardia (< 50bpm); however, patients with asymptomatic right bundle branch block (RBBB) or 1st degree AV block, in the absence of known cardiac disease (e.g. coronary, valvular) are not excluded
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection,
• Symptomatic congestive heart failure,
• Unstable angina pectoris,
• Uncontrolled symptomatic cardiac arrhythmia,
• Psychiatric illness/social situations that would limit compliance with study requirements
• Diagnosed to have any of the following condition(s), and/or have undergone any one of the following procedure(s) =< 3 months prior to registration:
• Symptomatic thrombotic or hemorrhagic cerebral vascular accident
• Coronary bypass graft
• Angioplasty

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Metro-Minnesota CCOP — Saint Louis Park, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Chinese University of Hong Kong-Prince of Wales Hospital — Shatin, Hong Kong, China
• National University Hospital — Singapore, Singapore
• National Cancer Centre — Singapore, Singapore
• Johns Hopkins Singapore International Medical Centre — Singapore, Singapore

Full record on ClinicalTrials.gov

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