Unesbulin in Advanced Leiomyosarcoma (SUNRISELMS)

Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS) (SUNRISELMS)

Agents: Unesbulin in combination with dacabazine
Phase II/III
Status  Recruiting
Sponsor PTC Therapeutics

Further information: https://clinicaltrials.gov/ct2/show/NCT05269355

This study compares the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in patients with unresectable or metastatic, relapsed or refractory leiomyosarcoma (LMS) who have received at least 1 prior line of systemic therapy.

WHO is the trial for?

  • Patients with unresectable or metastatic, relapsed or refractory leiomyosarcoma arising at any anatomic site except bone
  • Patients must have progressive disease on at least one prior systemic therapy
  • Patients with prior therapy with dacarbazine or temozolomide are not allowed on the trial

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

This study aims to investigate a drug called unesbulin and is comparing the effectiveness of unesbulin when taken in combination with a chemotherapy called dacarbazine versus chemotherapy alone for the treatment of advanced leiomyosarcoma (LMS).

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 sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

This study is open for recruitment.

WHERE is the trial available?

The trial is being conducted in the US.

For further information please check here: https://clinicaltrials.gov/ct2/show/NCT05269355

Study contact: Patient Advocacy, phone +1-866-562-4620, email: medinfo@ptcbio.com

STUDY DESIGN: What does the study look like?

This study has two arms: Patients will be randomly assigned to receive the study medicine unesbulin in combination with dacarbazine, or dacarbazine plus placebo (substance with no active ingredient).

The study medicine is taken as a tablet twice weekly, dacarbazine is administered as infusion once every 21 days. The number of treatment cycles completed will vary for everyone. Participants may continue receiving treatment for as long as it is of benefit to them.


HOW do I get more information?

Patient organisations 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 organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.eu

CONNECT with other patients on this trial

If you want to connect with other patients considering or participating in this trial, you can find them here.

SHARE your experience

You want to share your experience on this trial?
Send us an e-mail to: info@sarcoma-patients.eu
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

Not yet available.

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.


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