NCT05266196

A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Salarius Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This rollover protocol allows continued access to seclidemstat (SP-2577) for patients who are still receiving clinical benefit on completed or closed Salarius sponsored studies.

Detailed description

The population for the rollover study should be consistent with the population defined in the parent study. The primary eligibility criteria for a patient to enter the rollover protocol is the participation and completion of a Salarius sponsored study with seclidemstat. Safety data and an evaluation of anti-tumor activity will be collected. Patients who have completed a prior study with seclidemstat and who are assessed by the Investigator to continue to benefit from ongoing treatment will be eligible.

Conditions

• Ewing Sarcoma
• Myxoid Liposarcoma
• Desmoplastic Small Round Cell Tumor
• Extraskeletal Myxoid Chondrosarcoma
• Angiomatoid Fibrous Histiocytoma
• Clear Cell Sarcoma
• Myoepithelial Tumor
• Low Grade Fibromyxoid Sarcoma
• Sclerosing Epithelioid Fibrosarcoma

Interventions

Type	Name	Description
DRUG	Seclidemstat	Treatment assigned as per parent protocol

Timeline

• Start date: 2022-01-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-03-04
• Last updated: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study