SunriseLMS: Unesbulin in Advanced Leiomyosarcoma

 

Agents: Unesbulin vs. Placebo
Phase II/III
Status Recruiting
Sponsor PTC Therapeutics

 

For further information please also consult ClinicalTrials.gov.

This study compares the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in advanced LMS who have received at least 1 prior line of systemic therapy.

 

WHO is the trial for?
  • Patients of 18 years or older with advanced leiomyosarcoma (LMS) of any anatomic site except bone sarcoma
  • Patients must have unresectable or metastatic, relapsed or refractory LMS
  • Patients must have received at least 1 prior systemic therapy for LMS
  • Overall health of the patient must be good (ECOG performance status of 0 or 1)

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

 This trail aims to investigate a study drug called unesbulin in combination with dacarbazine. The trial tries to find out whether unesbulin + dacarbazine or dacarbazine + placebo is more effective in patients with advanced leiomyosarcoma who have received at least one prior therapy. In addition, safety and tolerability of this drug combination are assessed.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to opt for a new therapy strategy. This trial will further support the research in sarcomas and potentially help other/future patients with this disease. The trial might or might not benefit you directly in your treatment outcome.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in several study centers in the US, Canada, Brazil, Australia, France, Spain and the UK and will be opened in more centers in 2023. For further information please check here.
Study contact: Patient Advocacy (US) 1-866-562-4620 or medinfo@ptcbio.com

STUDY DESIGN: What does the study look like?

 There are 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Patients in one group will be assigned to unesbulin + dacarbazine, the other group will receive placebo + dacarbazine. Patients will have twice the chance of being assigned to the unesbulin + dacarbazine group than the placebo group.

Unesbulin is taken as tablets twice weekly, and dacarbazine as intravenous infusion once every 21 days.

HOW do I get more information?

 Patient organizations supporting sarcoma and/or GIST patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving GIST and/or sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

Please find further information about the trial SunriseLMS by the company PTC Therapeutics here. This information was created by PTC Therapeutics and the link is provided with permission.

 

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