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An Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Vinorelbine in Elderly Patients With Advanced Non Small Lung Cell Cancer - Stage IV (VENUS-1)

NCT01684111 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-01-18

No results posted yet for this study

Summary

To investigate the maximum tolerated dose of BIBF 1120, safety and pharmacokinetics in escalating doses administered with Vinorelbine i.v. in elderly patients with advanced Non-Small Lung Cancer (Stage IV).

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

BIBF 1120

2 x 150 mg capsules, oral, daily (Start dose)

DRUG

Vinorelbine

25 mg/m2 i.v. on day 1 and 8 (three-week cycle)

Sponsors & Collaborators

Principal Investigators

  • Prof. Dr. Rudolf M. Huber, MD · Klinikum der Universität München, D-80336 München

  • Prof. Dr. Martin Wolf, MD · Klinikum Kassel GmbH, D-34125 Kassel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-01-31

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT01684111 on ClinicalTrials.gov