CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 43 enrolled
Drug / intervention
BIBF 1120 M + docetaxel M +4 moredrug
Likely dose
BIBF 1120 M + docetaxel M 60 mg/m2from 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.

Search/NCT00876460
NCT00876460Phase 1Completed
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A Phase I Study of Continuous, Concomitant Oral Treatment With BIBF 1120 and Docetaxel - a Phase I, Open-label, Dose-escalation Study in Japanese Patients With Stage IIIB/IV or Recurrent Non-small-cell Lung Cancer After Failure of Chemotherapy

Boehringer Ingelheim·interventional·Posted Apr 6, 2009·Updated Nov 17, 2016

In Brief

A Phase 1 clinical trial evaluating BIBF 1120 M + docetaxel M, BIBF 1120 M + docetaxel H, and 3 other interventions for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 43 participants across 2 sites.

Detailed Summary

To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2009
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2012
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.2 years ago

Interventions

BIBF 1120 M + docetaxel Mdrug

BIBF 1120 Medium dose bid + docetaxel 60 mg/m2

BIBF 1120 M + docetaxel Hdrug

BIBF 1120 Medium dose bid + docetaxel 75mg/m2

BIBF 1120 H + docetaxel Hdrug

BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2

BIBF 1120 L + docetaxel Mdrug

BIBF 1120 Low dose bid + docetaxel 60 mg/m2

BIBF 1120 H + docetaxel Mdrug

BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2