MLN0264 in Previously Treated Asian Participants With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C
Condition: Advanced Gastrointestinal Carcinoma; Gastroesophageal Junction Adenocarcinoma; Recurrent Gastric Adenocarcinoma; Recurrent Gastroesophageal Junction Adenocarcinoma; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Recurrent Gastrointestinal Carcinoma
MeSH terms: Carcinoma; Adenocarcinoma; Esophageal Neoplasms; Recurrence
Intervention: MLN0264
Intervention description: MLN0264 IV.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MLN0264; Advanced gastrointestinal carcinoma

Summary:

      The purpose of this study is to evaluate the effects of MLN0264 in previously treated Asian
      participants with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or
      Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl
      Cyclase C (GCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has Diagnosis of GI carcinoma with Immunohistochemistry/ Immunohistochemical (IHC)
             evidence of expression of GCC protein (H-score of 10 or greater), for which standard
             treatment is no longer effective or does not offer curative or life-prolonging
             potential.

          -  Has completed prior chemotherapy, immunotherapy or radiation therapy at least 4 weeks
             prior to enrollment (except for Avastin [bevacizumab] for which at least 8 weeks from
             its last administration should elapse prior to enrollment).

          -  Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the
             stomach or gastroesophageal junction with IHC evidence of expression of GCC indicated
             by an H-score of 10 or greater.

          -  Has completed prior chemotherapy, immunotherapy or radiation therapy at least 4 weeks
             prior to enrollment.

          -  Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors
             (RECIST) version 1.1 guidelines.

          -  Has Eastern Cooperative Oncology Group performance status of 0 or 1 (within 14 days
             prior to enrollment).

          -  Females must be 1-year postmenopausal, or even if surgically sterile, agree to use
             other acceptable forms of birth control.

          -  Has adequate organ and hematological function.

          -  Has 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

        Exclusion Criteria:

          -  Has Concurrent treatment or treatment within 4 weeks of study entry with any other
             investigational agent.

          -  Female participants who are in the lactation period, even if they discontinue
             breastfeeding, or have a positive pregnancy test during the Screening period.

          -  Has uncontrolled, clinically significant, symptomatic cardiovascular disease within 6
             months prior to enrollment.

          -  Has treatment with any medication that has a clinically relevant potential risk of
             prolonging the QT interval or inducing Torsades de Pointes that cannot be discontinued
             or switched to a different medication prior to starting study drug.

          -  Participants with electrocardiogram (ECG) abnormalities considered by the investigator
             to be clinically -significant, or repeated baseline prolongation of the rate-corrected
             QT interval millisecond (msec) of electrocardiograph (QTc).

          -  Ongoing or clinically significant active infection.

          -  Has signs of peripheral neuropathy.

          -  Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer
             treatment.

          -  Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first
             dose of study drug.

          -  Has any preexisting medical condition of sufficient severity to prevent full
             compliance with the study.

          -  Has past or concurrent history of neoplasm other than GI carcinoma (phase 1) or
             gastric adenocarcinoma (phase 2), except for curatively treated nonmelanoma skin
             cancer or in situ carcinoma of the cervix uteri.

          -  Known diagnosis of human immunodeficiency virus (HIV) infection.

          -  Has asymptomatic brain metastases.

          -  Has an alcohol or substance abuse disorder.

          -  Has positive test for hepatitis B surface antigen.

          -  History of hypersensitivity to any ingredient of MLN0264.