Clinical trial · Interventional
A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)
NCT05266196CI-TRIAL-00068382unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This rollover protocol allows continued access to seclidemstat (SP-2577) for patients who are still receiving clinical benefit on completed or closed Salarius sponsored studies.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Angiomatoid Fibrous Histiocytoma | Angiomatoid Fibrous Histiocytoma | ONTOLOGY_EXACT | 0.98 |
| Clear Cell Sarcoma | Clear Cell Sarcoma of Soft Tissue | ALIAS | 0.90 |
| Desmoplastic Small Round Cell Tumor | Desmoplastic Small Round Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Extraskeletal Myxoid Chondrosarcoma | Extraskeletal Myxoid Chondrosarcoma | ONTOLOGY_EXACT | 0.90 |
| Low Grade Fibromyxoid Sarcoma | Low Grade Fibromyxoid Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Myoepithelial Tumor | Myoepithelial Tumor | ONTOLOGY_EXACT | 0.98 |
| Myxoid Liposarcoma | Myxoid Liposarcoma | ONTOLOGY_EXACT | 0.98 |
| Sclerosing Epithelioid Fibrosarcoma | Sclerosing Epithelioid Fibrosarcoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Seclidemstat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single agent
- description
- Single agent seclidemstat, as assigned per parent protocol
- interventionNames
- Drug: Seclidemstat
- type
- EXPERIMENTAL
- label
- TC Combination
- description
- Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol
- interventionNames
- Drug: Seclidemstat
Primary outcomes (1)
- measure
- Length of time receiving study treatment
- timeFrame
- months on study where patients continue to receive clinical benefit, up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is currently enrolled in a Salarius-sponsored study that is approved to enroll into this rollover study, and are receiving seclidemstat as monotherapy or in combination with other study treatment per the parent protocol (i.e. topotecan and cyclophosphamide). The maximum time between discontinuing the parent protocol and starting this rollover protocol is 14 days. 2. Patient is currently benefiting from the treatment with seclidemstat monotherapy or combination treatment, as determined by the investigator 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements 4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures 5. Ability to understand and the willingness to sign a written informed consent document. 6. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of seclidemstat administration. Exclusion Criteria: 1. Patient has been permanently discontinued from study treatment in the parent study due to any reason, except for the purpose of entering this open label rollover study. 2. Pregnant and breastfeeding women are excluded from this study. The effects of seclidemstat on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with seclidemstat. 3. Patient is receiving prohibited concomitant therapy as described in Section 5.4.2 of the rollover protocol, or therapy not allowed in the parent protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.