Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Liposarcoma

Sarcoma, Ewing

Chondrosarcoma

Fibrosarcoma

Histiocytoma

Histiocytoma, Benign Fibrous

Desmoplastic Small Round Cell Tumor

Myoepithelioma

Liposarcoma, Myxoid

Sarcoma, Clear Cell

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Adipose Tissue

Neoplasms, Fibrous Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Myxoid Liposarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Topotecan

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Topoisomerase I Inhibitors

Enzyme Inhibitors

Twice-daily administration of oral seclidemstat

Twice daily administration of seclidemstat in combination with cyclophosphamide and topotecan

Twice daily administration of seclidemstat

Seclidemstat

250 mg/m2/day on Days 1 thru 5 of a 21-day cycle

0.75 mg/m2/day on Days 1 thru 5 of a 21-day cycle

Single agent, non-randomized, open label expansion in select sarcoma patients including myxoid liposarcoma and other sarcomas that share similar chromosomal translocations to Ewing sarcoma; AND dose expansion of the combination of seclidemstat with topotecan and cyclophosphamide in patients with Ewing sarcoma

The single agent expansion cohort of select sarcoma patients will enroll myxoid liposarcoma patients and patients with other sarcomas that share similar chromosomal translocations to Ewing sarcoma (FET-family translocations), including but not limited to desmoplastic small round cell tumor.

A safety lead-in dose escalation and dose expansion will be conducted assessing the combination of seclidemstat with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma.

Two cohorts with single-agent seclidemstat in patients with myxoid liposarcoma and in patients with other sarcomas with similar chromosomal translocations to Ewing sarcoma (FET-family translocations), and one cohort of Ewing sarcoma patients treated with seclidemstat in combination with topotecan and cyclophosphamide

Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas

Phase 1 Trial of the LSD1 Inhibitor Seclidemstat (SP 2577) With and Without Topotecan and Cyclophosphamide in Patients With Relapsed or Refractory Ewing Sarcoma and Select Sarcomas

To evaluate the safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma and select sarcomas. Toxicities will be graded in severity per the guidelines outlined in the NCI CTCAE version 5.0. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity.

To determine the maximum tolerated dose (MTD) of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma. Toxicities will be graded in severity per the guidelines outlined in the NCI CTCAE version 5.0. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity.

To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide.

To evaluate the effect of food on the pharmacokinetics of seclidemstat. Both fasted and fed PK samples will be taken.

To evaluate the anti-tumor activity of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide. Tumor response will be measured according to RECIST 1.1 criteria. Radiological assessments may be centrally collected and subjected to quality checks and review by a central imaging vendor at the discretion of Salarius.

National Pediatric Cancer Foundation

Salarius Pharmaceuticals, LLC

Single agent seclidemstat, as assigned per parent protocol

Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol

Treatment assigned as per parent protocol

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.

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.

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

• To assess pharmacokinetics of seclidemstat and metabolites in post-treatment tumor biopsies to compare partitioning of these analytes between tumor and plasma

Length of time receiving treatment with seclidemstat as single agent or in combination with assigned parent protocol therapy

Number of patients enrolled who received seclidemstat

Evaluate the safety and tolerability of seclidemstat by characterizing adverse events according to the most current version of CTCAE

Evaluate the anti-tumor activity of seclidemstat based upon imaging studies according to RECIST v1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas	NCT03600649	Ewing Sarcoma Myxoid Liposarc... Sarcoma,Soft Ti... Desmoplastic Sm... Extraskeletal M... Angiomatoid Fib... Clear Cell Sarc... Primary Pulmona... Myoepithelial T... Sclerosing Epit... Fibromyxoid Tum...	Seclidemstat Cyclophosphamid... Topotecan	12 Years -	Salarius Pharmaceuticals, LLC
A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)	NCT05266196	Ewing Sarcoma Myxoid Liposarc... Desmoplastic Sm... Extraskeletal M... Angiomatoid Fib... Clear Cell Sarc... Myoepithelial T... Low Grade Fibro... Sclerosing Epit...	Seclidemstat	12 Years -	Salarius Pharmaceuticals, LLC
Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas	NCT03600649	Ewing Sarcoma Myxoid Liposarc... Sarcoma,Soft Ti... Desmoplastic Sm... Extraskeletal M... Angiomatoid Fib... Clear Cell Sarc... Primary Pulmona... Myoepithelial T... Sclerosing Epit... Fibromyxoid Tum...	Seclidemstat Cyclophosphamid... Topotecan	12 Years -	Salarius Pharmaceuticals, LLC
A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)	NCT05266196	Ewing Sarcoma Myxoid Liposarc... Desmoplastic Sm... Extraskeletal M... Angiomatoid Fib... Clear Cell Sarc... Myoepithelial T... Low Grade Fibro... Sclerosing Epit...	Seclidemstat	12 Years -	Salarius Pharmaceuticals, LLC

Spots Global Cancer Trial Database for myoepithelial tumor