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

NCT03600649 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-11-21

No results posted yet for this study

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

Conditions

  • Ewing Sarcoma
  • Myxoid Liposarcoma
  • Sarcoma,Soft Tissue
  • Desmoplastic Small Round Cell Tumor
  • Extraskeletal Myxoid Chondrosarcoma
  • Angiomatoid Fibrous Histiocytoma
  • Clear Cell Sarcoma
  • Primary Pulmonary Myxoid Sarcoma
  • Myoepithelial Tumor
  • Sclerosing Epithelioid Fibrosarcoma
  • Fibromyxoid Tumor

Interventions

DRUG

Seclidemstat

Twice daily administration of seclidemstat

DRUG

Cyclophosphamide

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

DRUG

Topotecan

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

Sponsors & Collaborators

  • National Pediatric Cancer Foundation

    collaborator OTHER

  • Salarius Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2025-09-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600649 on ClinicalTrials.gov