EUCTR2004-002420-18-GB
Active, not recruiting
Not Applicable
A prospective, non-randomised, non-controlled, open label, multicentre phase II study: PTK 787/ZK222584 in patients with advanced neuroendocrine tumours - PTK878/ZK 222584 in patients with advanced NET
CHARITE Universitätsmedizin Berlin Campus Virchow-Klinikum0 sites35 target enrollmentMarch 16, 2005
Conditionseuroendocrine Tumour
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- euroendocrine Tumour
- Sponsor
- CHARITE Universitätsmedizin Berlin Campus Virchow-Klinikum
- Enrollment
- 35
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Measurable histologically and immunohistologically confirmed neuroendocrine tumour NET
- •2\) Tumour proliferation as measured by Ki67 15%
- •3\) Age \> 18 years
- •4\) WHO performance status 0\-2
- •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\) High grade NET (Ki67 \> 15%)
- •2\) Chemotherapy 4 weeks prior to study entry
- •3\) Embolisation or Chemoembolisation less than 3 months prior to study entry
- •4\) Not recovered from surgery and no surgery within 2 weeks
- •5\) Embolisation in the previous 3 months
- •6\) Investigational drugs within 4 weeks
- •7\) Pregnant or breast feeding
- •8\) Adults in reproductive potential not using an effective method (ie barrier method) of birth control
- •9\) Other contraindication are listed in section 3\.2\.3 of the protocol
Outcomes
Primary Outcomes
Not specified
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