EUCTR2004-002290-22-DE
Active, not recruiting
Not Applicable
Phase II open-label study to investigate the efficacy and safety of PTK787/ZK222584 orally administered once daily or twice daily at a total daily dose of 1250 mg as second-line monotherapy in patients with Stage IIIB or Stage IV non-small-cell lung cancer (NSCLC) - Efficacy and safety of PTK787/ ZK 222584 1250 mg daily as 2nd line monotherapy in NSCLC
Conditionson-Small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- on-Small Cell Lung Cancer (NSCLC)
- Sponsor
- Schering AG
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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