Clinical trial NCT05266196: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
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
Lead sponsor: Salarius Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of time receiving study treatment
timeFrame: months on study where patients continue to receive clinical benefit, up to 5 years
Secondary outcomes:
measure: Number of patients enrolled through study completion
timeFrame: Number of patients enrolled on study who continue to receive clinical benefit, up to 5 years
measure: Evaluate safety & tolerability utilizing the most current version of CTCAE
timeFrame: During treatment while on study and continuing to receive clinical benefit, up to 5 years
measure: Evaluate anti-tumor activity based upon imaging studies according to RECIST v1.1
timeFrame: During treatment while on study and continuing to receive clinical benefit, up to 5 years
Other outcomes:
measure: Assess PK profile, maximum plasma concentration (Cmax)
timeFrame: During treatment while on study and continuing to receive clinical benefit, up to 5 years
Locations:
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
Study officials:
References: