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
- 198
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A Main Study 1.2 mg daily AL102 AL102 1.2 mg Part A Main Study 2 mg Intermittent AL102 AL102 2 mg 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 B Placebo Placebo Placebo to match recommended dose regimen from Part A Open Label Extension AL102 AL102, recommended dose regimen from Part A, 1.2 mg daily
- 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 Confirmed overall response rate (ORR) defined as the proportion of subjects with ORR (CR and PR) by BICR based on RECIST v1.1.
Change in Tumor Volume Approximately 2 years Change from baseline in estimated tumor volume measured by T2 weighted (T2W) MRI or CT by BICR (based on RECIST v1.1)
Duration of response Approximately 2 years Duration of response defined by the time from confirmed 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.
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 clinical progression as assessed by the investigator or death by any cause
Patient reported outcome Approximately 2 years Change from baseline in pain assessment using GOunder/Desmoid Tumor Research Foundation (DTRF) DEsmoid Symptom Scale and Impact Scale (GODDESS) Desmoid Tumor Symptom Scale (DTSS)
Safety and Tolerability Approximately 2 years Evaluation of the safety and tolerability of AL102 in subjects with progressing desmoid tumors as defined by the frequency and severity of TEAEs and SAEs and the time to treatment discontinuation due to TEAE
Related Research Topics
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Trial Locations
- Locations (52)
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
City of Hope
🇺🇸Duarte, California, 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
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Scroll for more (42 remaining)Mayo Clinic🇺🇸Jacksonville, Florida, United States