MLN0264 in Previously Treated Asian Patients With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C

Gastroesophageal Junction Adenocarcinoma Clinical Trial

Official title:
A Phase 1/2 Trial 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)

Status Completed

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

Adenocarcinoma
Advanced Gastrointestinal Carcinoma
Carcinoma
Esophageal Neoplasms
Gastroesophageal Junction Adenocarcinoma
Metastatic Gastric Adenocarcinoma
Metastatic Gastroesophageal Junction Adenocarcinoma
Recurrent Gastric Adenocarcinoma
Recurrent Gastroesophageal Junction Adenocarcinoma
Recurrent Gastrointestinal Carcinoma

Clinical Trial Details

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

View Details

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