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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

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 weeks
Treatment ~ Varies
Follow Up ~during treatment while on study and continuing to receive clinical benefit, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and during treatment while on study and continuing to receive clinical benefit, up to 5 years for reporting.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Clear Cell Sarcoma of Soft Tissue (CCSST) is often treated with targeted therapies and chemotherapy. Seclidemstat, an LSD1 inhibitor, works by inhibiting the lysine-specific demethylase 1 enzyme, which plays a role in gene expression and cancer cell proliferation. This inhibition can lead to reduced tumor growth and increased cancer cell death. Other common treatments include tyrosine kinase inhibitors, which block signals needed for tumor growth, and traditional chemotherapy agents that kill rapidly dividing cells. These mechanisms are crucial for CCSST patients as they target the specific pathways and cellular processes that drive the growth and survival of cancer cells, potentially leading to better treatment outcomes.
Exploring Metabolic Adaptations to the Acidic Microenvironment of Osteosarcoma Cells Unveils Sphingosine 1-Phosphate as a Valuable Therapeutic Target.Synergistic Drug Combinations with a CDK4/6 Inhibitor in T-cell Acute Lymphoblastic Leukemia.Binding of TS1, an anti-keratin 8 antibody, in small-cell lung cancer after 177Lu-DOTA-Tyr3-octreotate treatment: a histological study in xenografted mice.

Find a Location

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

Seclidemstat Clinical Trial Eligibility Overview. Trial Name: NCT05266196 — Phase 1 & 2
Clear Cell Sarcoma of Soft Tissue Research Study Groups: TC Combination, Single agent
Clear Cell Sarcoma of Soft Tissue Clinical Trial 2023: Seclidemstat Highlights & Side Effects. Trial Name: NCT05266196 — Phase 1 & 2
Seclidemstat 2023 Treatment Timeline for Medical Study. Trial Name: NCT05266196 — Phase 1 & 2
~3 spots leftby Dec 2025