Seclidemstat + Chemotherapy for Ewing Sarcoma

Recruiting in Palo Alto (17 mi)

+15 other locations

Dr. Damon Reed, MD, Medical Oncologist ...

Overseen byDamon Reed, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Salarius Pharmaceuticals, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests seclidemstat alone and with other drugs in patients with specific types of sarcoma, especially those who haven't responded to other treatments. The treatment aims to block cancer growth and use chemotherapy to kill cancer cells.

Eligibility Criteria

This trial is for patients aged 12 and older, weighing at least 40 kg, with specific sarcomas including Ewing or related types that are relapsed/refractory to prior treatments. Participants must have good performance status, adequate organ function, and a life expectancy over four months. They should not have had certain recent treatments or uncontrolled illnesses.

Inclusion Criteria

My blood tests show normal organ function and I haven't needed a blood transfusion in the last week.

I am mostly active and can care for myself regardless of my age.

I am at least 12 years old and weigh 40 kg or more.

+3 more

Exclusion Criteria

I have had targeted radiation therapy recently.

Participation in a prior investigational study within 30 days prior to Cycle 1 Day 1 or within 5 half-lives of the investigational product

I haven't had any cancer treatments in the last 3 weeks.

+19 more

Participant Groups

The trial tests Seclidemstat alone in select sarcoma patients and in combination with Topotecan and Cyclophosphamide for those with Ewing sarcoma. It's an open-label study where all participants receive the drugs without being compared to a placebo or other treatment.

3Treatment groups

Experimental Treatment

Group I: Sarcomas with FET-family translocations, including demoplastic small round cell tumorsExperimental Treatment1 Intervention

Twice-daily administration of oral seclidemstat

Group II: Myxoid LiposarcomaExperimental Treatment1 Intervention

Twice-daily administration of oral seclidemstat

Group III: Ewing sarcoma, combination therapyExperimental Treatment3 Interventions

Twice daily administration of seclidemstat in combination with cyclophosphamide and topotecan

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: