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

Primary Purpose

Ewing Sarcoma, Myxoid Liposarcoma, Desmoplastic Small Round Cell Tumor

Status

Enrolling by invitation

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Seclidemstat

About this trial

This is an interventional treatment trial for Ewing Sarcoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sarcoma Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Single agent

TC Combination

Arm Description

Single agent seclidemstat, as assigned per parent protocol

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

Outcomes

Primary Outcome Measures

Length of time receiving study treatment

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 who received seclidemstat

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

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

Full Information

NCT ID

NCT05266196

First Posted

November 11, 2021

Last Updated

July 31, 2023

Sponsor

Salarius Pharmaceuticals, LLC

1. Study Identification

Unique Protocol Identification Number

NCT05266196

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

January 15, 2022 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Salarius Pharmaceuticals, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single agent

Arm Type

Experimental

Arm Description

Single agent seclidemstat, as assigned per parent protocol

Arm Title

TC Combination

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Seclidemstat

Other Intervention Name(s)

topotecan, cyclophosphamide

Intervention Description

Treatment assigned as per parent protocol

Primary Outcome Measure Information:

Title

Length of time receiving study treatment

Description

Length of time receiving treatment with seclidemstat as single agent or in combination with assigned parent protocol therapy

Time Frame

months on study where patients continue to receive clinical benefit, up to 5 years

Secondary Outcome Measure Information:

Title

Number of patients enrolled through study completion

Description

Number of patients enrolled who received seclidemstat

Time Frame

Number of patients enrolled on study who continue to receive clinical benefit, up to 5 years

Title

Evaluate safety & tolerability utilizing the most current version of CTCAE

Description

Evaluate the safety and tolerability of seclidemstat by characterizing adverse events according to the most current version of CTCAE

Time Frame

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

Title

Evaluate anti-tumor activity based upon imaging studies according to RECIST v1.1

Description

Evaluate the anti-tumor activity of seclidemstat based upon imaging studies according to RECIST v1.1

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Assess PK profile, maximum plasma concentration (Cmax)

Description

• To assess pharmacokinetics of seclidemstat and metabolites in post-treatment tumor biopsies to compare partitioning of these analytes between tumor and plasma

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Sarcoma Oncology Center

City

Santa Monica

State/Province

California

ZIP/Postal Code

90403

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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