NCT01042782

Phase I Study of Daily RAD001 in Combination With Mitomycin C in Patients With Advanced Gastric Cancer or Cancer of the Esophagogastric Junction

Phase I Study of Daily RAD001 Administered Orally in Combination With Mitomycin C, Administered Every Three Weeks to Patients With Advanced Gastric Cancer or Cancer of the Esophagogastric Junction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced gastric cancer are treated with a combination of RAD001 (everolimus) and Mitomycin C.

Detailed description

The purpose of this monocenter, single-arm, phase I trial is to determine the maximum-tolerated-dose, dose-limiting toxicity (DLT) and preliminary efficacy and safety of RAD001 in combination with Mitomycin C in patients with advanced gastric cancer.

Conditions

• Advanced Gastric Cancer
• Advanced Cancer of the Esophagogastric Junction

Interventions

Type	Name	Description
DRUG	RAD001 and MitomycinC	RAD001 tablets daily, 5mg, 7.5 mg or 10 mg (3 cohorts) Mitomycin C 5 mg/m2 i.v. every 3 weeks

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-01-06
• Last updated: 2012-08-03

Locations

1 site across 1 country: Germany