Trial · NCT03600649
Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas
NCT03600649, Phase 1, Unknown, Salarius Pharmaceuticals, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas. Trials, record NCT03600649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03600649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas
- NCT number
- NCT03600649
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Salarius Pharmaceuticals, LLC
- 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
- Seclidemstat, Cyclophosphamide, Topotecan
- First posted
- 2018-07-26
- Last updated
- 2023-11-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | From screening through at least 30 days after end of treatment, up to approximately 24 months | 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. |
| Secondary | Determine the maximum tolerated dose of SP-2577 as determined by dose limiting toxicities measured according to CTCAE version 5.0 | From screening through at least 30 days after end of treatment, up to approximately 24 months | 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. |
| Secondary | Characterization of the pharmacokinetics of SP-2577 as measured by peak plasma concentration | From screening through at least 30 days after end of treatment, up to approximately 24 months | To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide. |
| Secondary | Characterization of the pharmacokinetics of SP-2577 as measured by area under the curve | From screening through at least 30 days after end of treatment, up to approximately 24 months | To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide. |
| Secondary | Characterization of the pharmacokinetics of SP-2577 as measured by apparent clearance of seclidemstat | From screening through at least 30 days after end of treatment, up to approximately 24 months | To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide. |
| Secondary | Characterization of the pharmacokinetics of SP-2577 as measured by median half-life | From screening through at least 30 days after end of treatment, up to approximately 24 months | To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide. |
| Secondary | Food effects on the pharmacokinetics of SP-2577 as measured in both fasted and fed populations, primarily measured by apparent clearance. | From screening through at least 30 days after end of treatment, up to approximately 24 months | To evaluate the effect of food on the pharmacokinetics of seclidemstat. Both fasted and fed PK samples will be taken. |
| Secondary | Anti-tumor activity as measured according to RECIST 1.1 criteria based upon radiological assessments. | From screening through at least 30 days after end of treatment, up to approximately 24 months | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03600649
GET https://conductscience.org/api/trials/v1/NCT03600649/registered