NCT01349296

BIBF 1120 and RAD001 in Solid Tumors - Phase I

BARIS - BIBF1120 and RAD001 in Solid Tumors. A Phase I Trial to Evaluate the Safety and Tolerability of Combined BIBF 1120 and RAD001 in Solid Tumors and to Determine the Maximum Tolerated Dose (MTD) of the Combination

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

Summary

BIBF1120 and RAD001 in solid tumors

Detailed description

A phase I trial to evaluate the safety and tolerability of combined BIBF 1120 and RAD001 in solid tumors and to determine the maximum tolerated dose (MTD) of the combination

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Everolimus + BIBF 1120	Dose level 1: 1x 5mg Everolimus/d + 2x 150mg BIBF 1120/d. Dose level 2: 1x 5mg Everolimus/d + 2x 200mg BIBF 1120/d. Dose level 3: 1x 10mg Everolimus/d + 2x 200mg BIBF 1120/d

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-10-01
• Completion: 2016-05-01
• First posted: 2011-05-06
• Last updated: 2016-05-20

Locations

1 site across 1 country: Germany