MedDataX Logo

Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.

NCT ID: NCT00160043

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type EXPERIMENTAL

SH T00268C

Intervention Type DRUG

1250 mg experimental drug od

Arm 2

Group Type EXPERIMENTAL

PTK787/ ZK 222584

Intervention Type DRUG

1250 mg experimental drug bid (500mg + 750mg)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SH T00268C

1250 mg experimental drug od

Intervention Type DRUG

PTK787/ ZK 222584

1250 mg experimental drug bid (500mg + 750mg)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Non small cell lung cancer, Stage IIIB or Stage IV
* One and only 1 prior platinum-based chemotherapy
* No other uncontrolled concurrent illness
* Use of highly effective birth control methods in males or females with reproductive potential

Exclusion Criteria

* Previous participation in another trial within the last 4 weeks
* Surgery within 10 days prior to the start of study treatment
* Brain metastases
* Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
* Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
* Breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Paris, , France

Site Status

Paris, , France

Site Status

Villejuif, , France

Site Status

Göttingen, Lower Saxony, Germany

Site Status

Essen, North Rhine-Westphalia, Germany

Site Status

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France Germany

References

Explore related publications, articles, or registry entries linked to this study.

Gauler TC, Besse B, Mauguen A, Meric JB, Gounant V, Fischer B, Overbeck TR, Krissel H, Laurent D, Tiainen M, Commo F, Soria JC, Eberhardt WEE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26.

Reference Type RESULT
PMID: 21617019 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-002290-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

308801

Identifier Type: OTHER

Identifier Source: secondary_id

91411

Identifier Type: -

Identifier Source: org_study_id