This is a non-randomized, non-controlled, open label, multicenter phase II study to evaluate the efficacy and safety of PTK 787/ ZK 222584 in the treatment of patients with·progressive neuroendocrine tumors who will not qualify for curative resection of the tumor.
Conditions
Interventions
Product Name: not available
Product Code: PTK 787/ ZK222584
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
CAS Number: n. a.
Current Sponsor code: PTK 787/ ZK222584
Other descriptive
Sponsors
Prof. B. Wiedenmann, Klinik für Gastroenterologie, Charité, Campus Virchow
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 - Confirmed HIV infection - 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 which leads to malabsorption, malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets) - Second malignant tumor (except non-melanoma skin tumors and carcinoma in situ of the cervix) - Patients who are taking Coumadin (warfarin sodium) or other medication metabolized by cytochrome p450, heparin is acceptable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement/ extension of Time to progression;Secondary Objective: - Improvement of Response rate according to RECIST criteria or tumor stabilization in patients with progressive disease demonstrated within the last six months prior to start of PTK787/ZK 222584 therapy - Improvement/ extension of Survival time - Decrease of tumor markers ( Chromogranin A, 5-HIES) - Increase or stabilization of Body weight· - Improvement of Subjective general condition (WHO performance status) - Improvement of Quality of life (EORTC QLQ C30) - Toxicity and safety;Primary end point(s): Time to progression | — |
Countries
Germany, United Kingdom
Outcome results
None listed