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AL102 for Desmoid Tumors (RINGSIDE Trial)
RINGSIDE Trial Summary
This trial will test if a new drug, AL102, is safe and effective in treating patients with desmoid tumors.
RINGSIDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRINGSIDE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RINGSIDE Trial Design
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Who is running the clinical trial?
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- I need assistance with daily activities due to my health condition.I am 18 years old or older.I have a GI condition that could make diarrhea worse.I have recently been treated for desmoid tumors.I was diagnosed with cancer in the last 2 years.I have a history of serious heart conditions.I agree to give a sample of my tumor for testing.I do not have any ongoing infections that aren't under control.I do not have any severe or uncontrolled health issues.I can swallow pills and don't have stomach issues affecting drug absorption.My blood tests show abnormal organ or bone marrow function.My tumor has been confirmed as a desmoid tumor by a pathologist.I have either not been treated for my condition, or it has come back or didn't respond after one treatment.I am 12 or older, weigh at least 40 kg, have a growing desmoid tumor, and can consent to treatment.My tumor has grown by 10% or more recently, or my tumor pain isn't controlled by regular painkillers.I have a tumor that can be measured with an MRI.
- Group 1: Part A Main Study 2 mg Intermittent
- Group 2: Part A Main Study 1.2 mg daily
- Group 3: Part A Main Study 4 mg Intermittent
- Group 4: Part B AL102
- Group 5: Part B Placebo
- Group 6: Open Label Extension
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
So far, how many people have signed up to participate in this experiment?
"In order to carry out the planned research, a total of 192 people must meet the clinical study's inclusion criteria. The sponsor, Ayala Pharmaceuticals, Inc., will be conducting the trial at various locations including Ohio State University Wexner Medical Center in Columbus, Ohio and Oregon Health & Science University in Rochester, Minnesota."
In how many different geographical areas is this trial being conducted?
"Currently, this research is being conducted in 13 hospitals, with locations in Columbus, Rochester, Phoenix and 10 other cities. If enrolled in the study, it would be ideal to choose a location nearest you to limit travel as much as possible."
Are there any opportunities for new patients to join this clinical trial?
"Yes, the information on clinicaltrials.gov suggests that this clinical trial is actively searching for candidates. The trial was first posted on 3/30/2021 and was last updated on 10/30/2022. The trial is admitting 192 participants across 13 sites."
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