What side effects are associated with this type of intervention?

Common treatments for Clear Cell Sarcoma of Soft Tissue, including chemotherapy agents like doxorubicin and ifosfamide, and targeted therapies like pazopanib and regorafenib, are associated with a range of side effects. Doxorubicin can cause myelosuppression, alopecia, and mucosal inflammation, while ifosfamide may lead to neurotoxicity and hemorrhagic cystitis. Pazopanib is known for causing hypertension, hypothyroidism, and diarrhea, and regorafenib can result in asthenia, diarrhea, mucositis, acral erythema, anorexia, and arterial hypertension. LSD1 inhibitors like Seclidemstat may have unique side effects, but specific data on these are limited.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Clear Cell Sarcoma of Soft Tissue that directly target LSD1 or similar epigenetic mechanisms like Seclidemstat. However, treatments for soft tissue sarcomas in general have included various chemotherapeutic agents such as doxorubicin, ifosfamide, and pazopanib, a multikinase angiogenesis inhibitor. These treatments focus on different mechanisms, such as DNA damage and angiogenesis inhibition, rather than epigenetic modulation.

What other types of research exist?

Promising novel alternatives to Seclidemstat for Clear Cell Sarcoma of Soft Tissue patients include MLN0128, an ATP-competitive mTOR kinase inhibitor, which has shown potent antitumor activity in multiple sarcoma subtypes, and pazopanib, which demonstrated activity in various soft tissue sarcoma subtypes in phase II trials. Additionally, next-generation sequencing (NGS) may identify actionable targets for personalized treatment options.

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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

Approved for 20 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial allows patients who have previously benefited from seclidemstat to continue their treatment. Seclidemstat is a drug that aims to stop cancer cells from growing by blocking essential proteins. The trial targets patients who are still seeing positive results.

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.

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.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of time receiving study treatment

Secondary study objectives

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 study objectives

Assess PK profile, maximum plasma concentration (Cmax)

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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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.

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