Adenocarcinoma of the Stomach Clinical Trial
Official title:
A Phase 2 Trial of MLN0264 in Previously Treated Patients With Metastatic or Recurrent Adenocarcinoma of the Stomach or Gastroesophageal Junction Expressing Guanylyl Cyclase C (GCC)
The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in patients with recurrent or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the stomach or gastroesophageal junction.
The drug being tested in this study is called MLN0264. MLN0264 is being tested to treat
tumors in people who have metastatic or recurrent gastric or gastroesophageal junction
malignancies expressing guanylyl cyclase C (GCC). This study will assess tumor size
reduction in patients who are administered MLN0264.
The study will enroll 42 to 81 patients. All participants will be administered MLN0264 at
1.8 mg/kg as a single, 30-minute, intravenous (IV) infusion on Day 1 of each 3-week
treatment cycle, followed by a rest period of 20 days. Participants will continue to receive
MLN0264 for up to 1 year or until disease progression or unacceptable toxicity occurs.
This multi-centre trial will be conducted worldwide. The overall time to participate in this
study is approximately 19 months. Participants will make 3 to 6 visits to the clinic per
treatment cycle, an end-of-treatment visit 30 days after the last dose of study medication,
and follow-up assessments every 12 weeks until death or 6 months after the last patient
completes treatment - whichever occurs first.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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