Finding studies
Finding studies
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Lead
Michael Weichenthal
This is a multicenter, randomized, open-label, parallel-group phase II study to evaluate the efficacy and safety of PTK-ZK in the treatment of patients with metastatic malignant melanoma who do not qualify for surgical resection: * progressive locoregionary disease not to be controlled by surgical measures * distant metastasis other than brain metastasis not eligible for surgical resection or radiotherapy All patients will be treated with PTK-ZK 1250mg administered orally once a day for treatment cycles of 28 days. In case of unacceptable toxicity the dose can be reduced to 1000 mg and further on to 750 mg daily. Patients in Arm B additionally receive intravenous DTIC 850mg/m² on day 1 of each cycle. After informed consent is given by the patient a biopsy from a metastasis should be taken before the first intake of study medication and at the end of cycle 2 to specify markers of angiogenesis and MVD (Micro vessel density).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
