Study Of MK-2206 In Patients With Metastatic Neuroendocrine Tumors (NET)

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-07-21	Results First Submitted 2015-04-08	Last Update Submitted that met QC Criteria 2016-01-21
First Submitted that Met QC Criteria 2010-07-22	Results First Submitted that Met QC Criteria 2016-01-21	Last Update Posted (ESTIMATED) 2016-02-18
First Posted (ESTIMATED) 2010-07-26	Results First Posted 2016-02-18	Last Verified 2016-01

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: islet cell carcinomas and carcinoid tumors This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.	DRUG: MK-2206 MK-2206 will be given orally 200 mg qw as given in the prior Ph1 clinical trial that demonstrated safety, tolerability and adequate PK/PD values at this dose. Follow-up imaging scans will be performed every 12 weeks to evaluate response. Patients must tak

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: islet cell carcinomas and carcinoid tumors

This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.

DRUG: MK-2206

MK-2206 will be given orally 200 mg qw as given in the prior Ph1 clinical trial that demonstrated safety, tolerability and adequate PK/PD values at this dose. Follow-up imaging scans will be performed every 12 weeks to evaluate response. Patients must tak

Primary Outcome Measures	Measure Description	Time Frame
Overall Response.	Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.	every 12 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients with histologically or cytologically confirmed moderately to well differentiated metastatic or unresectable carcinoid or islet cell tumors.
Patient has at least one measurable lesion greater than or equal to 20 mm on CT or MRI imaging.
Patients who are on therapy with a somatostatin analog are eligible for entry but must be on a stable dose for at least 3 months with no evidence of tumor shrinkage during that time period.
Patient ≥18 years of age on the day of signing informed consent.
Patient has performance status 0-1 on the ECOG Performance Scale.
Patient has adequate organ function as indicated by the following laboratory values:
Absolute Neutrophil Count (ANC)≥1,500/mcL
Platelets ≥100,000/mcL
Hemoglobin ≥9 g/dL
Serum Creatinine ≤2 times the upper limit of normal (ULN)/ OR calculated CrCl ≥60 mL/min (patients with creatinine levels ≥2 times the ULN only). Patient may not be on dialysis
Serum total bilirubin ≤1.5 times the ULN
AST (SGOT) and ALT (SGPT) ≤5 times the ULN
HgbA1c ≤ 8%
Fasting Glucose ≤120 mg/dl
Creatinine clearance should be calculated by the Cockcroft-Gault method.Fasting is defined as at least 4 hours without oral intake.
Patient has voluntarily agreed to participate by giving written informed consent.
Previous local therapy (e.g. chemoembolization or bland embolization) is allowed if completed > 6 weeks or 5X half-life prior to study entry. For patients who received local therapy prior to study entry, there must be either documented growth of measurable disease within the embolization field or outside of the embolization field, or both, prior to study entry if the area of the embolization field was the only site of measurable disease.
Previous chemotherapy, radiotherapy, and/or biologic therapy, including investigational agents, is/are allowed if completed > 4 weeks prior to study entry (>6 weeks if last regimen contained bevacizumab, BCNU or mitomycin C, and > 6 weeks from last dose of radiation therapy or radiopharmaceutical.
Patients must not have disease that is currently amenable to curative surgery. Prior surgery is allowed no less than 6 weeks prior to study entry.
Patients with diabetes mellitus are eligible for study entry but must have controlled diabetes as defined by hemoglobin A1c <8.0% within 2 weeks of initiation of protocol therapy.

Patient has toxicities from prior therapies that have not resolved to grade 1 or grade 0.
Patient has known active CNS metastases and/or carcinomatous meningitis are excluded. However, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids that are used to minimize surrounding brain edema.
Patient has an active malignancy of metastatic potential other than the known carcinoid or islet cell tumor, for the past 3 years.
Patient has a known hypersensitivity to the components of study drug (MK-2206) or its analogs that is not treatable by premedication with antihistamines and steroids.
Patient has a condition, including but not limited to
symptomatic congestive heart failure
unstable angina pectoris
serious cardiac arrhythmia
history or current evidence of a myocardial infarction during the last 6 months, and/or a current ECG tracing that is abnormal in the opinion of the treating investigator
QTc prolongation >450 msec (Bazett's formula)
Patient with evidence of clinically significant bradycardia (HR <50), or a history of clinically significant bradyarrhythmias such as sick sinus syndrome, 2nd degree AV block (Mobitz Type 2).
Patient with uncontrolled hypertension (i.e., 160/90 mHg SiBP). Patients who are controlled on antihypertensive medication will be allowed to enter the study.
Patient at significant risk for hypokalemia (e.g., patients on high dose diuretics, or with recurrent diarrhea)
Patient is a known diabetic who is poorly controlled (HBAc>8%)
Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Patient is, at the time of signing informed consent, a regular user (including -recreational use‖) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
Patient is known to be Human Immunodeficiency Virus (HIV)-positive
Patient has known history of Hepatitis C or active Hepatitis A or B.
Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible.
Patient has prior treatment with an mTOR inhibitor such as afinitor, sirolimus, or temsirolimus.

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

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Caregivers

Clinical Trial Record