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

Sponsor

Salarius Pharmaceuticals, LLC (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05266196

Collaborator

(none)

Enrollment

Location

Arms

46.5

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ewing Sarcoma Myxoid Liposarcoma Desmoplastic Small Round Cell Tumor Extraskeletal Myxoid Chondrosarcoma Angiomatoid Fibrous Histiocytoma Clear Cell Sarcoma Myoepithelial Tumor Low Grade Fibromyxoid Sarcoma Sclerosing Epithelioid Fibrosarcoma	Drug: Seclidemstat	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single agent Single agent seclidemstat, as assigned per parent protocol	Drug: Seclidemstat Treatment assigned as per parent protocol Other Names: topotecan cyclophosphamide
Experimental: TC Combination Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol	Drug: Seclidemstat Treatment assigned as per parent protocol Other Names: topotecan cyclophosphamide

Arm

Intervention/Treatment

Experimental: Single agent

Single agent seclidemstat, as assigned per parent protocol

Drug: Seclidemstat

Treatment assigned as per parent protocol

Other Names:

topotecan

cyclophosphamide

Experimental: TC Combination

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

Drug: Seclidemstat

Treatment assigned as per parent protocol

Other Names:

topotecan

cyclophosphamide

Outcome Measures

Primary Outcome Measures

Length of time receiving study treatment [months on study where patients continue to receive clinical benefit, up to 5 years]
Length of time receiving treatment with seclidemstat as single agent or in combination with assigned parent protocol therapy

Secondary Outcome Measures

Number of patients enrolled through study completion [Number of patients enrolled on study who continue to receive clinical benefit, up to 5 years]
Number of patients enrolled who received seclidemstat
Evaluate safety & tolerability utilizing the most current version of CTCAE [During treatment while on study and continuing to receive clinical benefit, up to 5 years]
Evaluate the safety and tolerability of seclidemstat by characterizing adverse events according to the most current version of CTCAE
Evaluate anti-tumor activity based upon imaging studies according to RECIST v1.1 [During treatment while on study and continuing to receive clinical benefit, up to 5 years]
Evaluate the anti-tumor activity of seclidemstat based upon imaging studies according to RECIST v1.1

Other Outcome Measures

Assess PK profile, maximum plasma concentration (Cmax) [During treatment while on study and continuing to receive clinical benefit, up to 5 years]
• To assess pharmacokinetics of seclidemstat and metabolites in post-treatment tumor biopsies to compare partitioning of these analytes between tumor and plasma

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Patient is currently benefiting from the treatment with seclidemstat monotherapy or combination treatment, as determined by the investigator
Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
Ability to understand and the willingness to sign a written informed consent document.
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:

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.
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.
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.