Spots Global Cancer Trial Database for An Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV (VENUS-2)

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Trial Identification

Brief Title: An Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV (VENUS-2)

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

Study ID: NCT01683682

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

BIBF 1120

Vinorelbine

Carboplatin

Study Description

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

Detailed Description: Patients older than 70 years could be enrolled 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