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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ewing Sarcoma; Myxoid Liposarcoma; Desmoplastic Small Round Cell Tumor; Angiomatoid Fibrous Histiocytoma; Extraskeletal Myxoid Chondrosarcoma; Clear Cell Sarcoma; Myoepithelial Tumor; Sclerosing Epithelioid Fibrosarcoma; Low Grade Fibromyxoid Sarcoma
• Intervention / Treatment: Drug: Seclidemstat

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90403
      • Sarcoma Oncology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single agent; Single agent seclidemstat, as assigned per parent protocol	Drug: Seclidemstat; Treatment assigned as per parent protocol; Other Names: cyclophosphamide; topotecan
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: cyclophosphamide; topotecan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Salarius Pharmaceuticals, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Complex and Mixed; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Adipose Tissue; Neoplasms, Fibrous Tissue; Sarcoma; Sarcoma, Ewing; Liposarcoma; Liposarcoma, Myxoid; Chondrosarcoma; Sarcoma, Clear Cell; Fibrosarcoma; Histiocytoma; Desmoplastic Small Round Cell Tumor; Histiocytoma, Benign Fibrous; Myoepithelioma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Cyclophosphamide; Topotecan
• Other Study ID Numbers: SALA-004-RO21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No