Efficacy and Safety of Oral Treatment With BIBF 1120 ES in Advanced Non-small-cell Lung Cancer

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: BIBF 1120 ES high dose; Drug: Placebo to BIBF 1120 ES; Drug: BIBF 1120 ES low dose

• Registration Number: NCT02182050
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The overall purpose of this phase II trial was to evaluate the efficacy of 250 mg BIBF 1120 twice daily (BID) versus 150 mg BIBF 1120 BID in patients with advanced non-small-cell lung cancer (NSCLC) who had failed at least one prior chemotherapy regimen. In addition, safety data for the two different dosages were collected and analysed.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2007-01
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-08
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIBF 1120 ES high dose	BIBF 1120 ES high dose	-
Placebo	Placebo to BIBF 1120 ES	-
BIBF 1120 ES low dose	BIBF 1120 ES low dose	-

Primary Outcome Measures

Name	Time	Method
Tumour response according to response evaluation criteria in solid tumours (RECIST)	baseline, every 6 weeks for an expected mean observation duration of 9 months
Time to tumour progression	baseline, every 6 weeks for an expected mean observation duration of 9 months

Secondary Outcome Measures

Name	Time	Method
EORTC QLC lung cancer module (QLQ-LC13) score	mean observation duration of 9 months
Overall survival	mean observation duration of 9 months
Incidence and intensity of adverse events, graded by Common Terminology Criteria (CTCAE) 3.0	mean observation duration of 9 months
Changes in vital signs (body temperature, blood pressure, pulse rate, respiratory rate)	mean observation duration of 9 months
Maximum plasma concentration (Cmax)	pre-dose, 1, 2, and 3 hours after administration
Eastern Cooperative Oncology Group (ECOG) performance score	mean observation duration of 9 months
Area under the curve (AUC)	pre-dose, 1, 2, and 3 hours after administration
European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) score	mean observation duration of 9 months
Changes in safety laboratory parameters	mean observation duration of 9 months