A Study of MLN0264 in Participants With Cancer of the Stomach or Gastroesophageal Junction

Inclusion Criteria

• •1. Male or female participants 18 years of age or older when written informed consent is obtained.
• •2. Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the stomach or gastroesophageal junction with immunohistochemistry (IHC) evidence of guanylyl cyclase C (GCC) expression indicated by an H-score of 10 or greater.
• •3. Treatment with 1 or more prior chemotherapies for advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
• •4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. All scans and x-rays used to document measurable disease must be done within 28 days before enrollment (ascites and bone lesions are not considered measureable disease).
• •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days before enrollment.
• •6. Female participants who:
• •* Are postmenopausal for at least 1 year before the screening visit, OR
• •* Are surgically sterile, OR
• •* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or
• •* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)
• •Male participants, even if surgically sterilized (ie, status postvasectomy), who:
• •* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
• •* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\] and withdrawal are not acceptable methods of contraception.)
• •7. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
• •8. Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment:
• •* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• •* Platelet count ≥ 100 x 10\^9/L
• •* Hemoglobin ≥ 9 g/dL
• •* Activated partial thromboplastin time (aPTT) ≤ 1.5 x the upper limit of the normal range (ULN) per institutional laboratory normal range
• •* International normalized ratio (INR) ≤ 1.5 x ULN
• •* Serum creatinine ≤ 1.5 x ULN
• •* Total bilirubin ≤ 1.5 x ULN
• •* Albumin ≥ 3g/dL
• •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
• •* Serum lipase ≤ 3 x ULN and serum amylase within the normal range
• •9. Resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
• •10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.