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

Ewing Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05266196
• Other study ID #: SALA-004-RO21
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: January 15, 2022
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Salarius Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angiomatoid Fibrous Histiocytoma
• Chondrosarcoma
• Clear Cell Sarcoma
• Desmoplastic Small Round Cell Tumor
• Ewing Sarcoma
• Extraskeletal Myxoid Chondrosarcoma
• Fibrosarcoma
• Histiocytoma
• Liposarcoma
• Liposarcoma, Myxoid
• Low Grade Fibromyxoid Sarcoma
• Myxoid Liposarcoma
• Sarcoma
• Sarcoma, Clear Cell
• Sarcoma, Ewing
• Sclerosing Epithelioid Fibrosarcoma

Intervention

Drug:
• Seclidemstat
Treatment assigned as per parent protocol

Locations

Country	Name	City	State
United States	Sarcoma Oncology Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Salarius Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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