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

Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160043

Enrollment

112

Registered

2005-09-12

Start date

2005-03-31

Completion date

2008-11-30

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief summary

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

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.

Interventions

DRUGSH T00268C

1250 mg experimental drug od

DRUGPTK787/ ZK 222584

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Tumor response rate (complete or partial response according to RECIST).	At baseline and every 8 weeks afterwards

Secondary

Measure	Time frame
Time to disease progression.	At baseline and every 8 weeks afterwards

Countries

France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026