At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 41 enrolled
Drug / intervention
BIBF 1120drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120
In Brief
A Phase 1 clinical trial evaluating BIBF 1120 for Neoplasms. Completed, enrolled 41 participants across 11 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesFrance, Germany
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2004
First PostedJul 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedJul 15, 2008
Enrollment StartOct 1, 2004
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.0 years ago
Interventions
BIBF 1120drug