NCT01684111

An Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Vinorelbine in Elderly Patients With Advanced Non Small Lung Cell Cancer - Stage IV (VENUS-1)

An Open Label Phase I Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Vinorelbine in Elderly Patients With Advanced Non Small Lung Cell Cancer - Stage IV

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Aktion Bronchialkarzinom e.V. · Academic / Other
• Sex: All
• Age: 71 Years
• Healthy volunteers: Not accepted

Summary

To investigate the maximum tolerated dose of BIBF 1120, safety and pharmacokinetics in escalating doses administered with Vinorelbine i.v. in elderly patients with advanced Non-Small Lung Cancer (Stage IV).

Detailed description

Patients older than 70 years could be enroled in this clinical trial. The trial is being carried out in two trial centres in Germany. For the planned sample size it is assumed that two different dosage groups are needed with 6 patients on each dosage group with the option to deescalate the first dosage. Altogether this leads to an estimated sample size of maximal 18 patients. * Duration of treatment/patient: up to 6 month * Follow Up: at least 6 month

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	BIBF 1120	2 x 150 mg capsules, oral, daily (Start dose)
DRUG	Vinorelbine	25 mg/m2 i.v. on day 1 and 8 (three-week cycle)

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-01-01
• First posted: 2012-09-12
• Last updated: 2016-01-18

Locations

4 sites across 1 country: Germany