Spots Global Cancer Trial Database for Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma
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Trial Identification
Brief Title: Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma
Official Title: Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)
Study ID: NCT03600441
Conditions
Interventions
Study Description
Brief Summary: This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.
Detailed Description: Patients will be evaluated for objective response, Duration of Response (DOR), Progression Free Survival (PFS), Clinical Benefit Rate (CBR), Overall survival (OS), safety and tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and changes in health related quality of life. Patients may receive treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. An independent data safety monitoring committee (iDMC) will evaluate the data pertaining to the futility and decide whether the study should stop or continue to the second stage. If the study continues to the second stage, a total of 139 patients will be studied.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Advocate Medical Group - Park Ridge, Luther Lane - Oncology, Park Ridge, Illinois, United States
Norton Cancer Institute - St. Matthews Campus, Louisville, Kentucky, United States
Clinical Research Alliance Inc, Lake Success, New York, United States
Manhattan Hematology Oncology Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Bone Marrow Transplant Hematology Oncology Associates, Pittsburgh, Pennsylvania, United States
Arlington Cancer Center, Arlington, Texas, United States
Central Texas Veterans Health Care System - NAVREF, Temple, Texas, United States
Vista Oncology Inc. PS, Olympia, Washington, United States
Centre Hospitalier de Perpignan, Perpignan, Pyrénées-Orientales, France
Hospital Universitario de Donostia, Donostia-San Sebastián, Guipúzcoa, Spain
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
C.H. Regional Reina Sofia, Córdoba, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
Contact Details
Name: Connie W Batlevi, MD,PhD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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