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