MedDRA version: 6.1 Level: SOC Classification code 10038604
Conditions
Interventions
Product Name: PTK787/ZK 222584
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VATALANIB
Current Sponsor code: PTK787/ZK 222584
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
AZIENDA OSPEDALIERA S. FILIPPO NERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically and/or citologically proven HER-2/neu positive breast cancer Hercep Test score 3 or FISH-positivity; Metastatic breast cancer stage IV; age 18 years and 75 years; performance status 50 Karnofsky score ; Measurable or evaluable disease; Anthracycline and/o taxanes based chemotherapy trastuzumab for metastatic disease; Adquuate haematologica, hepatic and renal function; No serious cardiac, metabolic or neuologic disease; FEVS 50 No previous history of other tumors than basocellular carcinoma of the skin or adequately treated in situ carcinoma of cervix uteri; written informed consent 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: Absolute neutrophil count ANC 1.5 x 109 /L; Haemoglobin 10.0 gr/dL; platelet count 100 x 109/L; Significant liver function abnormality manifested by an increased in total bilirubin 1.5 mg/dL or ASAT/ALAT 3 times upper limit normal value 5 x ULN if liver metastases present ; Acute or chronic liver disease i.e. hepatitis, cirrhosis Significant renal function impairment serum creatinine 2.0 mg/dL or Chronic renal disease. Proteinuria based on dip stick reading positive 1 or if the dip stick result is 1, total urinary protein 500 mg and measured creatinine clearance CrCl 50 mL/min from a 24-hour urine collection Radiotherapy within 4 weeks; Life expectancy 12 weeks; Any previous angiogenesis inhibition therapy; Motor or sensory neurotoxicity grade 2; Serious cardiac disease; Surgery 10 days prior to the start of study treatment Inadequate recovery from previous surgery, radiation, chemo-biologic or immunotherapy. Uncontrolled diabetes Active uncontrolled infection Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study - Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen - Unstable angina pectoris - Symptomatic congestive heart failure - Myocardial infarction 6 months prior to randomization - Serious uncontrolled cardiac arrhythmia Impairment of gastrointestinal GI function or GI disease that may significantly alter the absorption of PTK787/ZK222584 i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction or inability to swallow the tablets History or presence of central nervous system CNS disease i.e. primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis ; Pregnant or lactating women; women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of study treatment; Patients of both genders with reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Definite contraindications for the use of corticosteroids as premedication;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To determine the maximum tolerated dose MTD and the pharmacokinetics interactions of weekly vinorelbine and PTK787/ZK222584 in combination with trastuzumab in MBC patients overexpressing HER-2 neu;Main Objective: To determine the mazimum tolerated dose MTD and the pharmacokinetics interactions of weekly vinorelbine and PTK787/ZK 222584 in combination with trastuzumab in MBC patients overexpressing HER-2 neu;Secondary Objective: To evaluate the tolerability and the optimal schedule of the combination of weekly vinorelbine, trastuzumab and PTK787/ZK222584 in pre-treated MBC patients, HER-2 | — |
Countries
Italy
Outcome results
None listed