Melanoma Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of Bosentan in Patients With Stage IV Metastatic Melanoma Treated With Dacarbazine
The study is designed as a multicenter, double blind, parallel-group, placebo-controlled, randomized, event driven Phase II study of DTIC with or without bosentan as first-line treatment in patients with stage IV melanoma.
This is a randomized, double-blind (1:1 bosentan : placebo) trial to evaluate the effect of
bosentan in combination with DTIC on TTP or death in patients with metastatic melanoma stage
IV.
The patients will receive study medication (bosentan or placebo) and DTIC for 35 weeks to
105 weeks; the study will be completed when 66 events (tumor progression, death due to
underlying disease, other/additional anti-tumor therapy) have been observed.
Study drug will be administered orally, 500 mg twice a day. DTIC will be given once every
three weeks in a dosage of 1000 mg/m2 intravenously (i.v.) or in accordance with the
Institution's DTIC treatment protocol.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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