SWOG clinical trial number
S1005

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

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Ph II MK-2206 gastric and GEJ
Activated
01/01/2011
Closed
05/01/2013
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Gastrointestinal Cancer

Treatment

MK-2206

Eligibility Criteria Expand/Collapse

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.

Publication Information Expand/Collapse

2015

A phase II study of MK-2206, an allosteric inhibitor of AKT as second line therapy for advanced gastric and gastroesophageal junction cancer, a SWOG cooperative group trial (S1005)

R Ramanathan;A McDonough;H Kennecke;S Iqbal;JC Baranda;T Seery;H Lim;AF Hezel;GM Vaccaro;CD Blanke Cancer, Jul 1;121(13):2193-2197

PMid: PMID25827820 | PMC number: PMC4589423

2014

A Phase II Study of MK-2206, an Allosteric Inhibitor of AKT as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction (GEJ) Cancer, a SWOG Cooperative Group Trial (S1005)

R Ramanathan;S McDonough;H Kennecke;S Iqbal;J Baranda;T Seery;H Lim;AF Hezel;G Vaccaro;CD Blanke Journal of Clinical Oncology 32:5s (suppl; abstr 4041); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), general poster session;