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

Phase 2 Completed 80 enrolled Actelion

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2005-09-30
Primary completion: 2008-02-29
Completion: 2008-02-29

Outcome

Missed primary endpoint

paper Median time to tumor progression (primary endpoint) was not significantly different between the two groups PMID 20350333 ↗

paper bosentan/placebo hazard ratio, 1.144; 95% CI, 0.717-1.827; p = 0.5683 PMID 20350333 ↗

Publications

Kefford RF, Clingan PR, Brady B, Ballmer A, Morganti A, Hersey P. A randomized, double-blind, placebo-controlled study of high-dose bosentan in patients with stage IV metastatic melanoma receiving first-line dacarbazine chemotherapy. Mol Cancer. 2010 Mar 30;9:69. doi: 10.1186/1476-4598-9-69.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bosentan	Other / unclassified	500 mg	Oral