An Open-label Phase II Study of BKM120 in Patients With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response rate
Objective Response rate is the number of patients in a cohort who experience either complete response (CR) or partial response (PR) during their follow-up after treatment start divided by the total number of patients included in the corresponding cohort
Treatment continues in cycles of 28 days until disease progression, intolerable toxicity, other criteria for discontinuation, or 6 months after the last patient in that cohort has started BKM120, whichever comes first.
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CBKM120Z2402
NCT01693614
February 2013
March 2015
Name | Location |
---|---|
MD Anderson Cancer Center/University of Texas Dept.ofMDAndersonCancerCtr(3) | Houston, Texas 77030-4009 |
Massachusetts General Hospital Dept of Onc | Boston, Massachusetts 02114 |
University of Massachusetts Medical Center Dept of Oncology | Worcester, Massachusetts 01655 |
University of Nebraska Medical Center Univ Nebraska | Omaha, Nebraska 68198 |
Memorial Sloan Kettering Cancer Center Dept of Onc. | New York, New York 10021 |
Medical University of South Carolina Medical Univ if South Carolina | Charleston, South Carolina 29425 |