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BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I

NCT00876460 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2016-11-17

Study results available
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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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

BIBF 1120 M + docetaxel M

BIBF 1120 Medium dose bid + docetaxel 60 mg/m2

DRUG

BIBF 1120 M + docetaxel H

BIBF 1120 Medium dose bid + docetaxel 75mg/m2

DRUG

BIBF 1120 H + docetaxel H

BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2

DRUG

BIBF 1120 L + docetaxel M

BIBF 1120 Low dose bid + docetaxel 60 mg/m2

DRUG

BIBF 1120 H + docetaxel M

BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-09-30
Completion
2015-07-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876460 on ClinicalTrials.gov