A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)

Salarius Pharmaceuticals

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Sclerosing Epithelioid Fibrosarcoma; Myoepithelial Tumor; Angiomatoid Fibrous Histiocytoma; Desmoplastic Small Round Cell Tumor; Low Grade Fibromyxoid Sarcoma; Clear Cell Sarcoma; Myxoid Liposarcoma; Ewing Sarcoma; Extraskeletal Myxoid Chondrosarcoma

Treatments: Drug: Seclidemstat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05266196

SALA-004-RO21

Details and patient eligibility

About

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.

Full description

The population for the rollover study should be consistent with the population defined in the parent study. The primary eligibility criteria for a patient to enter the rollover protocol is the participation and completion of a Salarius sponsored study with seclidemstat. Safety data and an evaluation of anti-tumor activity will be collected.

Patients who have completed a prior study with seclidemstat and who are assessed by the Investigator to continue to benefit from ongoing treatment will be eligible.

Enrollment: 10 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Single agent

Experimental group

Description:

Single agent seclidemstat, as assigned per parent protocol

Treatment:

Drug: Seclidemstat

TC Combination

Experimental group

Description:

Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol

Treatment:

Drug: Seclidemstat