Seclidemstat for Ewing Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ewing Sarcoma+10 MoreSeclidemstat - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer drug in patients with sarcoma, specifically those with myxoid liposarcoma or other sarcomas with similar chromosomal translocations to Ewing sarcoma. The trial will also test a combination of seclidemstat with topotecan and cyclophosphamide in patients with Ewing sarcoma.

Eligible Conditions
  • Ewing Sarcoma
  • Sclerosing Epithelioid Fibrosarcoma
  • Myoepithelial Tumor
  • Clear Cell Sarcoma of Soft Tissue
  • Fibromyxoid Tumor
  • Desmoplastic Small Round Cell Tumor
  • Soft Tissue Sarcoma
  • Extra Skeletal Myxoid Chondrosarcoma
  • Primary Pulmonary Myxoid Sarcoma
  • Angiomatoid Fibrous Histiocytoma
  • Myxoid Liposarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: From screening through at least 30 days after end of treatment, up to approximately 24 months

Month 24
Anti-tumor activity as measured according to RECIST 1.1 criteria based upon radiological assessments.
Characterization of the pharmacokinetics of SP-2577 as measured by apparent clearance of seclidemstat
Characterization of the pharmacokinetics of SP-2577 as measured by area under the curve
Characterization of the pharmacokinetics of SP-2577 as measured by median half-life
Characterization of the pharmacokinetics of SP-2577 as measured by peak plasma concentration
Determine the maximum tolerated dose of SP-2577 as determined by dose limiting toxicities measured according to CTCAE version 5.0
Food effects on the pharmacokinetics of SP-2577 as measured in both fasted and fed populations, primarily measured by apparent clearance.
Safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide measured by dose limiting toxicities and adverse events according to CTCAE version 5.0

Trial Safety

Trial Design

3 Treatment Groups

Ewing sarcoma, combination therapy
1 of 3
Sarcomas with FET-family translocations, including demoplastic small round cell ...
1 of 3
Myxoid Liposarcoma
1 of 3

Experimental Treatment

50 Total Participants · 3 Treatment Groups

Primary Treatment: Seclidemstat · No Placebo Group · Phase 1

Ewing sarcoma, combination therapyExperimental Group · 3 Interventions: Topotecan, Cyclophosphamide, Seclidemstat · Intervention Types: Drug, Drug, Drug
Sarcomas with FET-family translocations, including demoplastic small round cell tumors
Drug
Experimental Group · 1 Intervention: Seclidemstat · Intervention Types: Drug
Myxoid Liposarcoma
Drug
Experimental Group · 1 Intervention: Seclidemstat · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from screening through at least 30 days after end of treatment, up to approximately 24 months

Who is running the clinical trial?

Salarius Pharmaceuticals, LLCLead Sponsor
3 Previous Clinical Trials
33 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
10 Patients Enrolled for Ewing Sarcoma
National Pediatric Cancer FoundationOTHER
3 Previous Clinical Trials
110 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
72 Patients Enrolled for Ewing Sarcoma
Damon Reed, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
28 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Inclusion Criteria All patients must meet the following inclusion criteria in order to be enrolled in the study: 1
The patient should be at least 12 years old and weigh at least 40 kg.
The authors found that patients with Karnofsky ≥ 70% for over ≥ 16 years old and Lansky ≥ 70% for under 16 years old had an equivalent of Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.
The investigator believes that the patient will live for more than four months.
The investigators will ask patients if they are willing to provide tumor biopsies during screening and while they are being treated
The platelets in the blood were at a level of 100 billion per liter or more and there had been no transfusion within the past seven days.
As long as the total bilirubin level is ≤ 1.5 times the upper limit of normal or, in patients with Gilbert syndrome, the total bilirubin level is > 1.5 times the upper limit of normal as long as the direct bilirubin level is normal, the patient is considered to have a normal bilirubin level.
For patients with creatinine levels above normal, creatinine clearance must be 60 mL/min/1.73 m2 or greater to be considered for Kalydeco.
ANC ≥ 1.5 x 109/L An absolute neutrophil count of 1.5 x 109/L or greater is needed.