AL102 in Patients With Progressing Desmoid Tumors (RINGSIDE)

There is no translation available.

 

Trial name: AL102 in Patients With Progressing Desmoid Tumors (RINGSIDE)
Agents: AL 102 vs. placebo
Phase II/III
Status  Recruiting
Sponsor Ayala Pharmaceuticals, Inc

 

This is a Phase 2/3 randomized study for patients with progressive desmoid tumors: Further information: https://clinicaltrials.gov/ct2/show/NCT04871282

 

WHO is the trial for?

  • Patients with confirmed desmoid tumor (aggressive fibromatosis) that has progressed by ≥ 20% (measured by RECIST v1.1) within 12 months
  • At least 1 measurable lesion
  • One of the following:
    - Newly diagnosed patients whose disease is not amenable to surgery or
    - Recurrent/refractory disease following at least one line of therapy (including surgery, radiation, or systemic therapy)

WHAT is the key question that this trial is attempting to answer?

This study assesses the efficacy, safety and tolerability as well as quality of life (by patient-reported outcomes, PRO) of AL 102 in patients with newly diagnosed or progressing desmoid tumor / aggressive fibromatosis.

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in desmoid tumors/aggressive fibromatosis and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

More about the importance and benefits of joining clinical trials: Please click here.

WHEN will the trial be open?

 The study is recruiting.

WHERE is the trial available?

The trial is being conducted in several study centers in the US. For further information please check here.

Study contact:

Contact: Jason Kaplan, MD; +1-857-444-0553; Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser.
Contact: Johnathan Yoval, MD; Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser.

STUDY DESIGN: What does the study look like?

This study consists of two parts:
Part A has the objective to define the right dose. There is only one study arm.
Part B compares the efficacy and safety of AL 102 versus placebo (two study arms) in the dosing found in Part A.

In Part B, all participating patients will be randomly divided (by a computer) in two groups. Patients in one group will be assigned to AL 102, the other group will receive placebo.

HOW do I get more information?

Patient organisations supporting desmoid (or sarcoma) patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving desmoid, GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser.

SHARE your experience

You want to share your experience on this trial?
Send us an e-mail to: Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

No results are available at this time. Future results will be linked here.

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken