NCT01876641

Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib

Phase 1/2 Study Epigenetic Modification of BRAF-mutated Metastatic Melanoma: Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Mohammed M Milhem · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the combination of Vemurafenib with Decitabine plus Cobimetinib improves the low therapy response rate in subjects with malignant melanoma.

Detailed description

The primary objective of the Phase I portion of this study is to evaluate the safety and tolerability of the proposed schedule of decitabine and Vemurafenib plus Cobimetinib in the treatment of metastatic melanoma.

Conditions

• Metastatic Melanoma
• Melanoma
• BRAF-mutated Metastatic Melanoma
• V600EBRAF-mutated Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Vemurafenib + Cobimetinib, Decitabine

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-06-01
• Completion: 2018-09-01
• First posted: 2013-06-12
• Last updated: 2018-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study