Unesbulin for Leiomyosarcoma

(SUNRISELMS Trial)

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: PTC Therapeutics

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new drug combination of unesbulin and dacarbazine in patients with advanced LMS who have not responded to previous treatments. The goal is to see if unesbulin can help stop cancer growth and make dacarbazine more effective. Dacarbazine is an anticancer drug that has been used to treat various types of cancers.

Research Team

Mark Rance, MD

Principal Investigator

PTC Therapeutics

Eligibility Criteria

This trial is for adults with advanced Leiomyosarcoma (LMS) who have tried at least one other treatment. They should not have had major surgery or certain cancer treatments in the last few weeks and must be mostly recovered from previous therapy side effects, except hair loss. People with well-controlled breathing issues or liver metastases can join, but those with recent serious injuries, certain past cancers, or conditions that could affect drug absorption cannot.

Inclusion Criteria

My asthma or COPD is well-managed.

My cancer has spread to my liver.

I have had at least one treatment for LMS, including drugs like doxorubicin.

Exclusion Criteria

I haven't had cancer treatment or radiation in the last 3 weeks.

I have recovered from major surgery or serious injury within the last 4 weeks.

I don't have stomach issues affecting drug absorption.

Treatment Details

Interventions

• Dacarbazine (Alkylating agents)
• Placebo (Other)
• Unesbulin (Other)

Trial Overview The study tests Unesbulin combined with Dacarbazine against a placebo plus Dacarbazine in patients whose LMS cannot be surgically removed or has spread and did not respond to prior treatments. The goal is to see if Unesbulin helps better than no active treatment when both are given alongside Dacarbazine.

Participant Groups

Group I: Unesbulin and Dacarbazine Experimental Treatment 2 Interventions

Participants will receive unesbulin 300 milligrams (mg) tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/meter squared (m\^2) intravenously (IV) once every 21 days. Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.

Group II: Placebo and Dacarbazine Placebo Group 2 Interventions

Participants will receive placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.

Dacarbazine is already approved in Canada for the following indications:

Approved in Canada as Dacarbazine for:

• Hodgkin lymphoma
• Melanoma
• Soft tissue sarcoma

Who Is Running the Clinical Trial?

PTC Therapeutics

Lead Sponsor

Trials

75

Recruited

6,300+

Dr. Matthew B. Klein

PTC Therapeutics

Chief Executive Officer since 2023

BA from the University of Pennsylvania, MD from Yale University School of Medicine, MS in Epidemiology from the University of Washington School of Public Health

Dr. Stuart W. Peltz

PTC Therapeutics

Chief Medical Officer since 2023

MD from Harvard Medical School