A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer

Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction that has progressed after first-line regimen, or is recurrent within 6 months after receiving adjuvant therapy. Pts must have had exactly 1 prior systemic tx regimen. Previous adjuvant (chemo)radiotherapy is permitted. Prior concurrent chemotherapy with radiation is not considered one prior regimen. Measurable disease. No known brain mets. Must not have received chemo or RT within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to reg. Must not have received prior tx with a PI3, AKT, or Mtor inhibitor. Toxicities from prior tx must have resolved to </= Grade 1 prior to reg. Not receiving or planning to receive any other investigational agents. Must be able to tolerate oral meds and must not have malabsorption or chronic diarrhea >/= Grade 2. Zubrod performance status 0-1. Within 14 days prior to registration: hemoglobin >/= 9 g/dL; ANC >/=1,500/mcL; platelets >/= 100,000/mcL; total bilirubin </= IULN; AST and ALT </= 2.5 x IULN (5.0 x IULN for liver mets); serum creatinine (mg/dL) </= IULN OR calculated creatinine clearance > 50 mL/min; INR </= 1.2 unless taking therapeutic doses of warfarin. Within 28 days prior to registration: CT scans or MRIs for measurable disease; fasting blood sugar </= 150 mg/dL; hemoglobin A1C < 7%; QTcF < 450 msec for males or < 470 msec for females. Within 42 days prior to registration: CT scans or MRIs for non-measurable disease. Must not have any of the conditions listed in Section 5.17 or 5.19. Must not be receiving concurrent treatment with drugs that are strong inducers or inhibitors of CYP3A4. HIV-positive patients on combination antiretroviral tx not eligible. Must not be pregnant or nursing. Patients of reproductive potential must have agreed to use two forms of contraception. No other prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.