check_circleStudy Completed

Cancer, Carcinoma, Non-Small Cell Lung

BAY43-9006 - Phase II study in Non-Small Cell Lung Carcinoma (NSCLC)

Trial purpose

The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer.
- If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer.
- If BAY43-9006 helps to slow the worsening of non-small cell lung cancer.
- If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
52
Trial Dates
April 2004 - April 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Krankenhaus GrosshansdorfGroßhansdorf, 22927, Germany
Completed
M. D. Anderson Cancer Center - University of TexasHouston, 77030, United States

Primary Outcome

  • Anti-cancer activity (eg, percentage of patients with confirmed complete responses (CR) and partial responses (PR) per RECIST (Response Evaluation Criteria in Solid Tumors) criteria in patients with stage IV non-small cell lung carcinoma (NSCLC)
    date_rangeTime Frame:
    First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Duration of stable disease
    date_rangeTime Frame:
    First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival
    date_rangeTime Frame:
    First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of subjects with stable disease (SD)
    date_rangeTime Frame:
    First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline of Health-Related Quality of Life (HRQOL) score assessed at Cycle 2, Cycle 4, and end of treatment (EOT)
    date_rangeTime Frame:
    From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment.
    enhanced_encryption
    Safety Issue:
    No

Trial design

A phase II multicenter uncontrolled trial of BAY43-9006 in patients with relapsed or refractory advanced non-small cell lung carcinoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1