drugset / Trial / NCT00715403

A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120

NCT00715403

Phase 1 Completed 41 enrolled Boehringer Ingelheim
Treatment

Summary

The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters. Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.

Timeline

Start
2004-10
Primary completion
2009-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Nintedanib Small molecule Oral

Indications