Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER)
NCT02452294 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2017-05-03
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
- 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
Sponsors & Collaborators
-
University Hospital Dresden
collaborator OTHER -
University Hospital Tuebingen
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2017-12-31
- Completion
- 2018-07-31
Countries
- Germany
Study Locations
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