Status and phase
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About
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria Part A:
At least 18 years of age (inclusive) at the time of signing the ICF.
Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent).
Disease progression, assessed locally by the investigator, defined as having at least one of the following:
At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only)
One of the following:
Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for re- confirmation of disease.
Must be able to swallow whole capsules with no GI condition affecting absorption; nasogastric or G-tube administration is not allowed.
Exclusion Criteria Part A:
Diagnosed with a malignancy in the past 2 years with some exceptions.
Current or recent (within 2 months of IP administration) GI disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at Screening.
Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, , symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of acute ischemia.
Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the subject associated with his or her participation in the study.
Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
Eastern Cooperative Oncology Group (ECOG) performance status ≥2
Abnormal organ and marrow function at Screening defined as:
ECG Exclusions (Part A only)
Any treatments for desmoid tumors within 4 weeks prior to first dose of investigational therapy; subject must have recovered from therapy related toxicity to < CTCAE Grade 2 or clinical baseline. Therapy includes:
Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP;
Inclusion Criteria Part B
For all other inclusion criteria refer to Part A inclusion criteria.
Exclusion Criteria Part B The subjects must be excluded from participating in the study if they meet any of the exclusion criteria for Part A, except where otherwise noted.
Primary purpose
Allocation
Interventional model
Masking
192 participants in 6 patient groups, including a placebo group
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Central trial contact
Johnathan Yovell, MD; Yelena Lalazar, RN, MPH
Data sourced from clinicaltrials.gov
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