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BIBF 1120 in Combination With Pemetrexed in Advanced Non Small Cell Lung Cancer (NSCLC)

NCT00979576 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-03-06

Study results available
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Summary

The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.

Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m\^2) and to determine the Recommended Dose (RD) for the phase II part.

Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m\^2) as compared to pemetrexed (500 mg/m\^2) + placebo

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

BIBF 1120 M + Pemetrexed

BIBF 1120 medium dose bid+ Pemetrexed 500 mg/m\^2

DRUG

BIBF 1120 H + Pemetrexed

BIBF 1120 high dose bid+ Pemetrexed 500 mg/m\^2

DRUG

BIBF 1120 RD + Pemetrexed

confirmed dose of BIBF 1120 bid + Pemetrexed 500 mg/m\^2

DRUG

BIBF 1120 L + Pemetrexed

BIBF 1120 low dose bid+ Pemetrexed 500 mg/m\^2

DRUG

BIBF 1120 Placebo + Pemetrexed

placebo BIBF 1120 bid + Pemetrexed 500 mg/m\^2

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-16
Primary Completion
2015-02-16
Completion
2015-02-16

Countries

  • Japan

Study Locations

More Related Trials

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 NCT00979576 on ClinicalTrials.gov