A phase II, multi-centre, open-label, uncontrolled study to evaluate the efficacy and safety of BAY 43-9006 given daily in combination with repeated 21-day cycles of dacarbazine (DTIC) chemotherapy in...

Update Il y a 4 ans
Reference: EUCTR2004-000725-30

A phase II, multi-centre, open-label, uncontrolled study to evaluate the efficacy and safety of BAY 43-9006 given daily in combination with repeated 21-day cycles of dacarbazine (DTIC) chemotherapy in subjects with advanced metastatic melanoma

Woman and Man

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Extract

To evaluate the overall tumour response rate (including complete responses (CR) and partial responses (PR)) of oral BAY 43-9006 given continuously in combination with repeated 21-day cycles of dacarbazine, in subjects with advanced, metastatic melanoma. The response rate will be determined using the RECIST criteria


Inclusion criteria

  • Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable. Subjects should have measurable and evaluable disease (as per the RECIST criteria), and not have received prior cytotoxic chemotherapy

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