NCT01843738

Radiation Use During Vemurafenib Treatment

Radiation Use During Vemurafenib and Cobimetinib Treatment in Patients With BRAFV600 Mutated Stage IV or Unresectable Stage III Melanoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients are being asked to take part because they have melanoma that has spread to other organs in their body (metastatic). As part of this study, patients will receive radiation therapy and an approved drug (Vemurafenib).

Detailed description

Patients will be treated with vemurafenib plus radiation therapy (RT) based upon the administration schedule. The starting dose of vemurafenib will be the patient's baseline tolerating dose, between 720 - and 960 mg by mouth. Patients must be tolerating at a minimum 720mg for one cycle (28 days) prior to enrollment.

Conditions

• BRAFV600 Mutation
• Stage IV Melanoma

Interventions

Type	Name	Description
RADIATION	Radiation therapy	Per standard of care
DRUG	Vemurafenib	The starting dose of vemurafenib will be the patient's baseline tolerating dose, between 720 - and 960 mg PO bid.

Timeline

• Start date: 2017-06-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2013-05-01
• Last updated: 2017-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study