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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160043
• Other study ID #: 91411
• Secondary ID: 2004-002290-2230
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 14, 2014
• Start date: March 2005
• Est. completion date: November 2008

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• SH T00268C
1250 mg experimental drug od
• PTK787/ ZK 222584
1250 mg experimental drug bid (500mg + 750mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (1)

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 WE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as se — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response rate (complete or partial response according to RECIST).		At baseline and every 8 weeks afterwards	Yes
Secondary	Time to disease progression.		At baseline and every 8 weeks afterwards	Yes

External Links

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