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
- Conditions
- euroendocrine Tumour
- Registration Number
- EUCTR2004-002420-18-GB
- Lead Sponsor
- CHARITE Universitätsmedizin Berlin Campus Virchow-Klinikum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 35
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Examine time to progression in patients with advanced neuroendocrine tumours receiving PTKZK 787;Secondary Objective: Examine<br>1) Response Rate<br>2) Overall survival<br>3) Biochemical response<br>4) Body weight<br>5) Performance Status and Quality of Life<br>6) Toxicity and safety;Primary end point(s): Time to tumour progression
- Secondary Outcome Measures
Name Time Method