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AL102 for Desmoid Tumors (RINGSIDE Trial)

Phase 2 & 3
Waitlist Available
Led By Mrinal Gounder, MD
Research Sponsored by Ayala Pharmaceuticals, Inc,
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age (inclusive) at the time of signing the ICF
Must be able to swallow whole capsules with no GI condition affecting absorption
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

RINGSIDE Trial Summary

This trial will test if a new drug, AL102, is safe and effective in treating patients with desmoid tumors.

Who is the study for?
This trial is for adults with desmoid tumors that are growing and causing pain not controlled by non-opioid medication. Participants must have at least one tumor measurable by MRI, be able to swallow capsules, and can be treatment-naïve or have tried other treatments without success.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of a drug called AL102 compared to a placebo in patients with progressive desmoid tumors. The goal is to see if AL102 can help control the growth of these tumors better than no active treatment.See study design
What are the potential side effects?
While specific side effects for AL102 aren't listed here, common ones may include digestive issues, fatigue, skin reactions, liver changes, muscle or joint pain. Placebo pills usually don't cause side effects but taking them means missing out on potential benefits from active drugs.

RINGSIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I can swallow pills and don't have stomach issues affecting drug absorption.
Select...
My tumor has been confirmed as a desmoid tumor by a pathologist.
Select...
My tumor has grown by 10% or more recently, or my tumor pain isn't controlled by regular painkillers.
Select...
I have a tumor that can be measured with an MRI.

RINGSIDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival
Secondary outcome measures
Duration of response
Overall response rate
Patient reported outcome

RINGSIDE Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B AL102Experimental Treatment1 Intervention
AL102, recommended dose regimen from Part A, 1.2 mg daily
Group II: Part A Main Study 4 mg IntermittentExperimental Treatment1 Intervention
AL102 4 mg
Group III: Part A Main Study 2 mg IntermittentExperimental Treatment1 Intervention
AL102 2 mg
Group IV: Part A Main Study 1.2 mg dailyExperimental Treatment1 Intervention
AL102 1.2 mg
Group V: Open Label ExtensionExperimental Treatment1 Intervention
AL102, recommended dose regimen from Part A, 1.2 mg daily
Group VI: Part B PlaceboPlacebo Group1 Intervention
Placebo to match recommended dose regimen from Part A

Find a Location

Who is running the clinical trial?

Ayala Pharmaceuticals, Inc,Lead Sponsor
3 Previous Clinical Trials
151 Total Patients Enrolled
Mrinal Gounder, MDPrincipal InvestigatorMSKCC
2 Previous Clinical Trials
429 Total Patients Enrolled

Media Library

AL102 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04871282 — Phase 2 & 3
Desmoid Tumors Research Study Groups: Part A Main Study 2 mg Intermittent, Part A Main Study 1.2 mg daily, Part A Main Study 4 mg Intermittent, Part B AL102, Part B Placebo, Open Label Extension
Desmoid Tumors Clinical Trial 2023: AL102 Highlights & Side Effects. Trial Name: NCT04871282 — Phase 2 & 3
AL102 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04871282 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~38 spots leftby Jan 2025