EUCTR2004-002420-18-DE
Active, not recruiting
Phase 1
A prospective, non-randomized, non-controlled, open label, multicenter phase II Study: PTK 787/ ZK222584 in patients with advanced neuroendocrine tumors. - not available
Prof. B. Wiedenmann, Klinik für Gastroenterologie, Charité, Campus Virchow0 sites54 target enrollmentFebruary 11, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Prof. B. Wiedenmann, Klinik für Gastroenterologie, Charité, Campus Virchow
- Enrollment
- 54
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically and immunohistologically confirmed neuroendocrine carcinoma
- •\- Neuroendocrine tumor of foregut, midgut, hindgut or CUP with demonstrated progress within the last 6 months
- •\- KI 67 \< 15%
- •\- Presence of measurable tumor lesions as determined by RECIST criteria
- •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
- •\- High grade malignant neuroendocrine tumor (Ki 67 \>15%)
- •\- Chemotherapy 4 weeks prior to entry on this study
- •\- Embolisation or chemoembolisation less than 3 month prior to entry on this study
- •\- Major surgery within 2 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy
- •\- Patients who have received investigational drugs within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
- •\- Patients who are pregnant or breast feeding
- •\- Adults of reproductive potential not employing an effective method of birth control (such as barrier methods). Oral, implantable or injectable contraceptives are not considered effective for this study due to potential CYP450 interaction
- •\- Current severe or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease or active uncontrolled infection) which could compromise participation in the study
- •\- Acute or chronic active liver disease (e.g., hepatitis, cirrhosis)
- •\- Presence of clinically symptomatic brain metastasis
Outcomes
Primary Outcomes
Not specified
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