NCT02452294

Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER)

An Open-label, Uncontrolled, Single Arm Phase II Trial of Buparlisib in Patients With Metastatic Melanoma With Brain Metastases Not Eligible for Surgery or Radiosurgery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will enrol adult female and male patients with BRAF wild-type melanoma and brain metastases who are not eligible for surgery or radiosurgery and failed prior therapy with ipilimumab, and patients with BRAF V600 mutation-positive melanoma and brain metastases who are not eligible for surgery or radiosurgery and who failed prior therapy with a BRAF inhibitor.

Conditions

• Malignant Melanoma
• Metastases

Interventions

Type	Name	Description
DRUG	Buparlisib	Patients will receive oral buparlisib 100 mg once daily and continue on study treatment until evidence of disease progression, death, or unacceptable adverse events

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-12-01
• Completion: 2018-07-01
• First posted: 2015-05-22
• Last updated: 2017-05-03

Locations

2 sites across 1 country: Germany