Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)

NCT01169649 | Completed Phase 2 Results DMC

• 1 other identifier: 10-067
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a new drug called MK-2206. This study is a phase II study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer. MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we hope that MK-2206 may stop the cancer cells from further growth and dividing. This study will help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine tumor.

Conditions

PANCREAS; Neuroendocrine

Keywords

MK-2206; Neuroendocrine Tumors; 10-067

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

islet cell carcinomas and carcinoid tumors

EXPERIMENTAL

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

Drug: MK-2206

Interventions

MK-2206 DRUG

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 take MK-2206 orally at least 2 hours before or 2 hours after food or a meal.

islet cell carcinomas and carcinoid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

MK 2206

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Dr. Diane Reidy-Lagunes
• Organization: Memorial Sloan Kettering Cancer Center

reidyd@mskcc.org

646-888-4185

Study Officials

• Diane Reidy-Lagunes, MD,MS

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 18, 2016
• Results First Posted: February 18, 2016

Record last verified: 2016-01

Locations

US (1)