Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Product Name: PTK787/ZK 222584
Product Code: SHT00268C
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vatalanib
CAS Number: 212142-18-2
Current Sponsor code: PTK787/ZK 222584
Other descr
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females aged at least 18 years or greater 2. Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV 3. One and only 1 prior first-line chemotherapy or chemo-radiotherapy regimen 4. At least 1 measurable lesion as per RECIST criteria (see Section Attachment 4) 5. World Health Organization (WHO) performance status of 0 to 1 6. Function of major organ systems: a. Hematopoietic: - Hemoglobin: greater than or equal to 9 g/dL - Absolute neutrophil count: greater than or equal to 1,500/mm3 - Platelet count: greater than or equal to 100,000/mm3 b. Hepatic: - Bilirubin: less than or equal to 1.5 times the upper limit of normal (ULN) - AST/ALT: less than or equal to 2.5 times the ULN (less than or equal to 5 times the ULN if liver metastases are present) c. Renal: - Creatinine: less than or equal to 1.5 times the ULN - Urinalysis: negative for proteinuria; d. No other uncontrolled concurrent illness 7. Life expectancy greater than or equal to 3 months 8. Negative pregnancy test (females of childbearing potential only) 9. Agreement by male and female patients with reproductive potential, to use double barrier contraceptive methods of birth control throughout their entire participation in the study. 10. 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
Exclusion criteria: 1. Prior anti-VEGF therapy 2. Time period < 14 days between end of prior first-line therapy (not including investigational drugs) and start of study treatment 3. Use of investigational drugs < 4 weeks prior to start of study treatment or inadequate recovery from any toxic effects of such therapy 4. Surgery < 10 days prior to study enrollment (i.e., informed consent) 5. Inadequate recovery from previous surgery, radiation, or chemotherapy 6. Candidacy for curative resection 7. Brain metastases 8. Medical conditions requiring urgent intervention including, but not limited to: a. Unstable and uncontrolled hypertension b. Active infection c. Superior vena cava syndrome d. Lobar obstruction e. Spinal cord compression f. Hyponatremia (< 130 mmol/L) g. Unstable angina pectoris 9. Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study including, but not limited to: a. Myocardial infarction within 6 months of study b. Symptomatic congestive heart failure c. Uncontrolled diabetes d. Chronic renal disease e. Acute or chronic liver disease other than liver metastases (e.g., hepatitis, cirrhosis) f. Psychiatric illness/social situations that would limit study participation 10. Confirmed diagnosis of infection with the human immunodeficiency virus (HIV) 11. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) 12. Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication 13. Breast feeding 14. Unwillingness or inability to comply with the protocol 15. Previous receipt of study treatment under this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Response rate after 12 weeks of study treatment.;Main Objective: To investigate the clinical efficacy of PTK787/ZK222584 as second-line monotherapy in patients with Stage IIIB/IV NSCLC ;Secondary Objective: (1) To investigate the safety and tolerability of the above treatment; (2) To investigate the pharmacodynamic activity of the above treatment | — |
Countries
Germany
Outcome results
None listed