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UnknownNCT03600649

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

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

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGSeclidemstatTwice daily administration of seclidemstat
DRUGCyclophosphamide250 mg/m2/day on Days 1 thru 5 of a 21-day cycle
DRUGTopotecan0.75 mg/m2/day on Days 1 thru 5 of a 21-day cycle

Timeline

Start date
2018-06-04
Primary completion
2025-09-01
Completion
2025-12-01
First posted
2018-07-26
Last updated
2023-11-21

Locations

16 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03600649. Inclusion in this directory is not an endorsement.