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Seclidemstat Access for Sarcoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Salarius Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during treatment while on study and continuing to receive clinical benefit, up to 5 years
Awards & highlights
Study Summary
This trial allows patients who are benefiting from the drug to continue taking it.
Who is the study for?
This trial is for patients who have been part of previous Salarius studies and are still benefiting from Seclidemstat, either alone or with other treatments. They must follow the study rules, use contraception if they can have children, and not be pregnant or breastfeeding. People can't join if they were taken off the original study treatment for any reason except to join this new one.Check my eligibility
What is being tested?
The trial provides ongoing access to Seclidemstat (SP-2577) for those already seeing positive effects from it in past trials by Salarius. It's a rollover protocol which means patients continue with the same medication without interruption.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants should expect similar reactions as observed in prior studies involving Seclidemstat. These could include typical drug-related adverse events such as nausea, fatigue, or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during treatment while on study and continuing to receive clinical benefit, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during treatment while on study and continuing to receive clinical benefit, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of time receiving study treatment
Secondary outcome measures
Evaluate anti-tumor activity based upon imaging studies according to RECIST v1.1
Evaluate safety & tolerability utilizing the most current version of CTCAE
Number of patients enrolled through study completion
Other outcome measures
Assess PK profile, maximum plasma concentration (Cmax)
Trial Design
2Treatment groups
Experimental Treatment
Group I: TC CombinationExperimental Treatment1 Intervention
Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol
Group II: Single agentExperimental Treatment1 Intervention
Single agent seclidemstat, as assigned per parent protocol
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Who is running the clinical trial?
Salarius Pharmaceuticals, LLCLead Sponsor
4 Previous Clinical Trials
145 Total Patients Enrolled
1 Trials studying Clear Cell Sarcoma of Soft Tissue
50 Patients Enrolled for Clear Cell Sarcoma of Soft Tissue
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in a Salarius study and taking seclidemstat, with no more than a 14-day break between studies.I am responding well to my current seclidemstat treatment.I agree to use birth control during the study and will report any pregnancy immediately.I am willing and able to follow the study's schedule and procedures.
Research Study Groups:
This trial has the following groups:- Group 1: TC Combination
- Group 2: Single agent
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
Are we able to enroll more people in this research project?
"This research study, which was last updated on February 23rd 2022 according to clinicaltrials.gov, is not looking for new participants at this time. Although 513 other studies are still recruiting patients."
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