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Alkylating agents
Seclidemstat + Chemotherapy for Ewing Sarcoma
Phase 1
Waitlist Available
Led By Damon Reed, MD
Research Sponsored by Salarius Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal organ and marrow function as defined: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L with no transfusion 7 days prior to labs, total bilirubin ≤ 1.5 x ULN or > 1.5 x ULN if direct bilirubin is normal, AST and ALT ≤ 3 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above normal
Age ≥ 12 years and weight ≥ 40 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening through at least 30 days after end of treatment, up to approximately 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug in patients with sarcoma, specifically those with myxoid liposarcoma or other sarcomas with similar chromosomal translocations to Ewing sarcoma. The trial will also test a combination of seclidemstat with topotecan and cyclophosphamide in patients with Ewing sarcoma.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions from the immune system affecting various organs, blood disorders due to bone marrow suppression by chemotherapy agents like Cyclophosphamide, digestive issues from both chemo drugs, fatigue from overall treatment burden.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal organ function and I haven't needed a blood transfusion in the last week.
Select...
I am at least 12 years old and weigh 40 kg or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening through at least 30 days after end of treatment, up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening through at least 30 days after end of treatment, up to approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide measured by dose limiting toxicities and adverse events according to CTCAE version 5.0
Secondary outcome measures
Anti-tumor activity as measured according to RECIST 1.1 criteria based upon radiological assessments.
Characterization of the pharmacokinetics of SP-2577 as measured by apparent clearance of seclidemstat
Characterization of the pharmacokinetics of SP-2577 as measured by area under the curve
+4 moreTrial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Topotecan
2017
Completed Phase 3
~2400
Find a Location
Who is running the clinical trial?
Salarius Pharmaceuticals, LLCLead Sponsor
4 Previous Clinical Trials
105 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
10 Patients Enrolled for Ewing Sarcoma
National Pediatric Cancer FoundationOTHER
4 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
72 Patients Enrolled for Ewing Sarcoma
Damon Reed, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
28 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had targeted radiation therapy recently.I haven't had any cancer treatments in the last 3 weeks.My blood tests show normal organ function and I haven't needed a blood transfusion in the last week.My brain cancer is getting worse or causing symptoms.I still have side effects from previous treatments that are not mild.I have been treated with LSD1 inhibitors for cancer.I haven't taken any oral tyrosine kinase inhibitors in the last 14 days.I haven't taken long-acting bone marrow stimulants in the last 14 days or short-acting ones in the last 7 days.I agree to use contraception while on this trial.I am mostly active and can care for myself regardless of my age.I have not had major surgery in the last 3 weeks.I am HIV-positive and on combination antiretroviral therapy.I am at least 12 years old and weigh 40 kg or more.I have a history of cancer.I am taking medications that cannot be stopped before starting the trial.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't had cancer in the last 5 years, except for skin cancer.I have had a bone marrow or stem cell transplant within the last 84 days.I am willing to provide tumor biopsies, unless it's not safe for me or I'm under 18.I haven't had immunotherapy in the last 28 days.I am not currently on any cancer treatment or experimental drugs.I have had a condition where my lymphocytes grow abnormally.I do not have uncontrolled heart disease or abnormal heart rhythms.
Research Study Groups:
This trial has the following groups:- Group 1: Myxoid Liposarcoma
- Group 2: Sarcomas with FET-family translocations, including demoplastic small round cell tumors
- Group 3: Ewing sarcoma, combination therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what indications is Seclidemstat ordinarily prescribed?
"Seclidemstat has been approved to effectively treat multiple sclerosis and is also being explored for its potential efficacy against leukemia, myelocytic acute sarcoma, and retinoblastoma."
Answered by AI
What is the current number of medical facilities that are conducting this experiment?
"Fox Chase Cancer Center in Philadelphia, Sarcoma Oncology Research Center in Santa Monica and H. Lee Moffitt Cancer Center and Research Institute in Tampa are a few of the 16 sites that are currently enrolling patients for this study."
Answered by AI
Are there any additional research projects which have utilized Seclidemstat?
"Seclidemstat was initially investigated in 1997 by the City of Hope Comprehensive Cancer Center, with 1213 studies having been completed since then. 853 are actively recruiting participants at this moment, with many being conducted in Philadelphia, Pennsylvania."
Answered by AI
Are there still opportunities to participate in this experiment?
"According to the details found on clinicaltrials.gov, this research is actively recruiting patients. First posted in June 2018 and last edited in August 2022, it is currently open for enrollment."
Answered by AI
How many individuals are currently participating in this trial?
"Affirmative. The clinical trial's information hosted on clinicaltrials.gov reveals that the study, which was initially posted on June 4th 2018, is still in search of volunteers. Up to 50 participants are necessary from 16 distinct medical sites."
Answered by AI
Has Seclidemstat received regulatory approval by the FDA?
"Seclidemstat has not undergone extensive clinical trials, so its safety is rated as a 1. This reflects the fact that Phase 1 of this medication's testing only provides minor evidence on efficacy and security."
Answered by AI
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