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Clinical Trial Summary

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


Clinical Trial Description

The drug being tested in this study is called MLN0264. This drug is being evaluated to check the effects on previously treated Asian individuals with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2). The study will enroll approximately 95 patients.

In Phase 1, approximately 14 Asian patients with GI malignancies will be enrolled in 3 planned dose cohorts according to the traditional 3 + 3 dose escalation scheme. The starting dose will be 1.2 mg/kg of MLN0264 administered IV on Day 1 of 3-week cycles for up to 1 year or until disease progression or unacceptable toxicity occurs. Dose escalation will take place until Phase 2 recommended dose is determined.

In Phase 2, eligible Asian patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction will be enrolled. Patients must have failed at least 2 lines of prior anticancer therapy for advanced or metastatic disease. Disease recurrence within 6 months of the last dose of post-surgical adjuvant chemotherapy counts as 1 line of prior anticancer therapy for advanced disease.

This multi-centre trial will be conducted in Japan, Korea and Taiwan. The overall time to participate in this study is up to 3 years. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02391038
Study type Interventional
Source Millennium Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2015
Completion date October 2015

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