Glioblastoma multiforme MedDRA version: 7.1 Level: PT Classification code 10018337
Conditions
Interventions
Product Name: PTK787/ZK 222584
Product Code: SH T00268C
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vatalanib
CAS Number: 212142-18-2
Current Sponsor code: PTK787/ZK 222584
Other desc
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histologically proven newly diagnosed GBM (according to local pathologist) amenable to concomitant and adjuvant temozolomide treatment by investigator's assessment. ? Interval between first surgery/biopsy and start of radiotherapy less than 6 weeks (42 days) and interval from the last surgical procedure and the start of radiotherapy more than 8 days (to allow healing prior to start of radiotherapy and adjuvant treatment) ? Start of radiotherapy within 8 days of randomization ? No prior chemotherapy, radiotherapy or prior anti-VEGF therapy. ? Patients should not be receiving EIADs. Patients under EIADS should be switched to no EIADs prior to study entry (refer to chapter 5.7). ? All patients (male and female) must use effective contraception if of reproductive potential. Females must not be pregnant or lactating. ? ECOG Performance status 450msec in males and >470msec in females. No history of stroke. ? No previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma. ? Absence of any unstable systemic diseases or active uncontrolled infections. Absence of uncontrolled hypertension. ? No concomitant treatment with warfarine or other coumarine derivatives. No concomitant treatment with other anti cancer agents and with any other experimental treatment. ? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial. ? Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess activity of PTK787/ZK 222584 given concomitantly and as adjuvant to radiotherapy and temozolomide in newly diagnosed GBM by determining progression free survival at 6 months after documentation of toxicity profile of the combination.;Secondary Objective: ;Primary end point(s): For the phase I part: To determine the safety / tolerance of PTK/ZK during the induction phase of treatment in combination with radiation therapy and temozolomide. For the phase II part: Progression free survival at 6 months. | — |
Countries
Austria, Belgium, Germany, Italy, United Kingdom
Outcome results
None listed