A Study of AL102 in Patients With Progressing Desmoid Tumors
- Registration Number
- NCT04871282
- Lead Sponsor
- Ayala Pharmaceuticals, Inc,
- Brief Summary
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
- Detailed Description
This is a Phase 2/3, randomized study in subjects with progressive desmoid tumors consisting of 2 parts. Phase2/Part A is an open-label, dose regimen finding study; Phase3/Part B is a double blind, placebo-controlled study and Open Label Extension utilizing the dose regimen selected in Phase2/Part A.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 192
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open Label Extension AL102 AL102, recommended dose regimen from Part A, 1.2 mg daily Part A Main Study 1.2 mg daily AL102 AL102 1.2 mg Part B Placebo Placebo Placebo to match recommended dose regimen from Part A Part A Main Study 4 mg Intermittent AL102 AL102 4 mg Part B AL102 AL102 AL102, recommended dose regimen from Part A, 1.2 mg daily Part A Main Study 2 mg Intermittent AL102 AL102 2 mg
- Primary Outcome Measures
Name Time Method Progression free survival Approximately 2 years Progression free survival (PFS) as defined as the time from randomization until the date of assessment of progression (as assessed by BICR based on RECIST v1.1) or death by any cause
- Secondary Outcome Measures
Name Time Method Overall response rate Approximately 2 years Overall response rate (ORR) defined as the proportion of subjects with ORR (CR and PR) by BICR based on RECIST v1.1.
Duration of response Approximately 2 years Duration of response defined by the time from CR or PR (by BICR based on RECIST v1.1) until the earlier of the first documentation of disease progression or death from any cause.
Patient reported outcome Approximately 2 years Change from baseline in pain assessment using brief pain inventory (BPI) short form
Trial Locations
- Locations (52)
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
City of Hope
🇺🇸Duarte, California, United States
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Adelaide Cancer Centre
🇦🇺Kurralta Park, South Australia, Australia
University of Pittsburgh Medical Center, Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Catalan Institute of Oncology (ICO)
🇪🇸Barcelona, Spain
ASAN Medical Center
🇰🇷Seoul, Korea, Republic of
Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
The Royal Marsden Hospital
🇬🇧London, United Kingdom
UTSW Simmons Cancer Center
🇺🇸Dallas, Texas, United States
The Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Mannheim university medical center
🇩🇪Mannheim, Germany
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
IRCCS Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
IRCCS Fondazione Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Vall d´Hebrón University Hospital
🇪🇸Barcelona, Spain
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Sarcoma Oncology Research Center
🇺🇸Santa Monica, California, United States
University of California at Los Angeles Hematology/Oncology
🇺🇸Santa Monica, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Campus Bio-Medico University Hospital
🇮🇹Rome, Italy
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Rambam MC
🇮🇱Haifa, Israel
Universitair Ziekenhuis
🇧🇪Gent, Belgium
Maria Sklodowska-Curie National Research Institute of Oncology
🇵🇱Warsaw, Poland
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
Oncology Institute Barzilai Medical Center
🇮🇱Ashkelon, Israel
Hadassah University Hospital - Ein Kerem
🇮🇱Jerusalem, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States