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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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

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