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

NCT05266196 | Unknown Phase 1 FDA Drug

• 1 other identifier: SALA-004-RO21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of patients enrolled through study completion

  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

  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

  During treatment while on study and continuing to receive clinical benefit, up to 5 years

Other Outcomes (1)

• Assess PK profile, maximum plasma concentration (Cmax)

  During treatment while on study and continuing to receive clinical benefit, up to 5 years

Study Arms (2)

Single agent

EXPERIMENTAL

Single agent seclidemstat, as assigned per parent protocol

Drug: Seclidemstat

TC Combination

EXPERIMENTAL

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

Drug: Seclidemstat

Interventions

Seclidemstat DRUG

Treatment assigned as per parent protocol

Also known as: topotecan, cyclophosphamide

Single agent; TC Combination

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salarius Pharmaceuticals, LLC: lead

Study Sites (1)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

MeSH Terms

Conditions

Sarcoma, Ewing; Liposarcoma, Myxoid; Desmoplastic Small Round Cell Tumor; Chondrosarcoma, Extraskeletal Myxoid; Histiocytoma, Angiomatoid Fibrous; Sarcoma, Clear Cell; Myoepithelioma

Interventions

seclidemstat; Topotecan; Cyclophosphamide

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Liposarcoma; Neoplasms, Adipose Tissue; Neoplasms, Complex and Mixed

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: March 4, 2022
• Study Start: January 15, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)