Spots Global Cancer Trial Database for Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)

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Trial Identification

Brief Title: Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)

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

Study ID: NCT01009177

Conditions

Melanoma

Interventions

Bosentan

Placebo

Study Description

Brief Summary: 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.

Detailed Description: 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.