NCT02050321

A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We propose to conduct a phase 2 study to assess whether the addition of acitretin to vemurafenib therapy is able to decrease the rate of cutaneous squamous cell carcinoma (cSCC) development, a known side effect of vemurafenib therapy, in patients with advanced melanoma. Further, we seek a preliminary assessment as to whether the addition of acitretin to vemurafenib enhances the clinical efficacy of this anti-melanoma agent.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Acitretin	A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
DRUG	Vemurafenib	A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-12-01
• Completion: 2015-07-01
• First posted: 2014-01-30
• Last updated: 2018-12-26
• Results posted: 2017-04-19

Locations

1 site across 1 country: United States