Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Gastroesophageal Junction, Diffuse Gastric Adenocarcinoma, Gastric Intestinal Type Adenocarcinoma, Gastric Mixed Adenocarcinoma, Recurrent Gastric Carcinoma

In brief

This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients with advanced gastric or gastroesophageal junction 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

NCT01260701

Run by

National Cancer Institute (NCI)

People needed

75

Starts

2011-01-01

Expected to finish

2015-07-01

Last updated by the study team

2016-01-18

Who can join

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

You may qualify if…

• Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction that has progressed after first-line treatment, or is recurrent within 6 months after receiving adjuvant therapy; patients must have had exactly one prior systemic treatment regimen; previous adjuvant (chemotherapy [chemo]) radiotherapy is permitted; prior chemotherapy given concurrently with radiation for radiosensitization is not considered one prior systemic regimen
• Patients must have measurable disease; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
• Patients must not have known brain metastases
• Patients must not have received chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
• Patient must not have received prior treatment with a phosphatidylinositol 3 (PI3), v-akt murine thymoma viral oncogene homolog 1 (AKT) or mechanistic target of rapamycin (Mtor) inhibitor for any reason
• All toxicities from prior therapy must have resolved to =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) prior to registration
• Patients must not be receiving or planning to receive any other investigational agents
• Patients must be able to tolerate oral medications and must not have malabsorption or chronic diarrhea (CTCAE version 4.0 grade 2 or higher); administration through a feeding tube is not permitted
• Hemoglobin >= 9 g/dL
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin =< institutional upper limit of normal (IULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 x IULN; patients with liver metastases must have AST and ALT =< 5 x IULN
• Patients must have adequate kidney function as evidenced by at least ONE of the following:
• Serum creatinine (mg/dL) =< IULN obtained within 14 days prior to registration
• Calculated creatinine clearance > 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
• Patients must have international normalized ratio (INR) =< 1.2 unless taking therapeutic doses of warfarin; this result must be obtained within 14 days prior to registration
• Patients must have fasting blood sugar =< 150 mg/dL within 28 days prior to registration
• Patients must have hemoglobin A1C < 7% within 28 days prior to registration
• Patients must have an electrocardiogram (ECG) within 28 days prior to registration; patients must have corrected QT interval (QTcF) (by Fridericia's calculation) < 450 msec (male) or < 470 msec (female)
• Patients must have a Zubrod performance status of 0-1
• Patient must not have any of the following: a history of congenital long QT syndrome; use of concomitant medications that could prolong the QTc interval; New York Heart Association class III or IV heart failure; history of myocardial infarction within 6 months prior to registration; uncontrolled dysrhythmias; poorly controlled angina; resting heart rate =< 50 bpm (bradycardia)
• Patients must not be receiving concurrent treatment with drugs that are strong inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); patients must be able to safely discontinue treatment with these agents for >= 2 weeks prior to beginning protocol therapy
• Patient must not have uncontrolled intercurrent 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
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Where it is running

• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• The University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
• The University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
• Fowler Family Center for Cancer Care — Jonesboro, Arkansas, United States
• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Front Range Cancer Specialists — Fort Collins, Colorado, United States
• Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• UF Cancer Center at Orlando Health — Orlando, Florida, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• Oncare Hawaii Inc-POB II — Honolulu, Hawaii, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• OnCare Hawaii-Liliha — Honolulu, Hawaii, United States
• Kuakini Medical Center — Honolulu, Hawaii, United States
• Oncare Hawaii Inc-Kuakini — Honolulu, Hawaii, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Castle Medical Center — Kailua, Hawaii, United States
• Wilcox Memorial Hospital and Kauai Medical Clinic — Lihue, Hawaii, United States
• Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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