Phase-II study to investigate the efficacy and safety of ZK 219477 as second-line therapy in patients with Stage IIIB or Stage IV non-small-cell lung cancer (NSCLC)

• Conditions: on small cell lung cancer (NSCLC) stage IIIB or stage IV

• Registration Number: EUCTR2005-000586-19-DE
• Lead Sponsor: Bayer Schering Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Males or females aged = 18 years

2. Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV

3. At least 1 unidimensionally measurable lesion (suitable for modRECIST
evaluation)

4. WHO performance status 0 to 1

5. Treatment failure of one previous platinum-based chemotherapy regimen

6. Time period since prior therapy:
- Prior radiotherapy: = 3 weeks
- Prior chemotherapy: = 3 weeks
- Prior immunotherapy: = 3 weeks

7. Adequate recovery (excluding alopecia) from previous surgery, radiation, and
chemotherapy

8. Adequate function of major organs and systems
• Nervous system:
- No Grade 2 or greater peripheral neuropathy
• Hematopoietic:
- Hemoglobin: = 10 g/dL
- WBC: = 3,000/mm3
- Absolute neutrophil count: = 1,500/mm3
- Platelet count: = 100,000/mm3
• Hepatic:
- Total bilirubin: normal
- AST/ALT: = 2.5 times the upper limit of normal
• Renal:
- Creatinine: = 2 mg/dL
• Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No arrhythmia needing continuous treatment
• No other uncontrolled concurrent illness

9. Survival expectation = 3 months

10. Negative pregnancy test at enrollment (females of childbearing potential only)

11. Agreement to use highly effective contraception methods (intra-uterine
contraceptive device IUCD, condoms, oral contraceptives, or other adequate
barrier contraception) in females of child-bearing potential

12. Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than one previous chemotherapy regimen for advanced disease

2. Prior treatment with epothilones

3. Use of any investigational drug within 4 weeks before start of study treatment
or inadequate recovery from any toxic effects of such therapy

4. Candidacy for curative resection

5. Symptomatic brain metastases requiring whole-brain irradiation

6. Active infection

7. Breast feeding

8. Any condition that in the opinion of the investigator could hamper the
compliance with the study protocol

9. History of any other primary malignancy with the exceptions of non- melanoma skin cancer and carcinoma in situ of the cervix

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of ZK 219477 in platinum-pretreated patients with NSCLC (proof of concept) ;Secondary Objective: To investigate the safety and tolerability of the above treatment;Primary end point(s): Proportion of patients with either CR or PR as ‘best overall response’