Angiomatoid Fibrous Histiocytoma, Clear Cell Sarcoma, Desmoplastic Small Round Cell Tumor, Ewing Sarcoma, Extraskeletal Myxoid Chondrosarcoma, Low Grade Fibromyxoid Sarcoma, Myoepithelial Tumor, Myxoid Liposarcoma, Sclerosing Epithelioid Fibrosarcoma
Conditions
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.
Interventions
DRUGSeclidemstat
Treatment assigned as per parent protocol
Sponsors
Salarius Pharmaceuticals, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of time receiving study treatment | months on study where patients continue to receive clinical benefit, up to 5 years | Length of time receiving treatment with seclidemstat as single agent or in combination with assigned parent protocol therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Evaluate the anti-tumor activity of seclidemstat based upon imaging studies according to RECIST v1.1 |
| Number of patients enrolled through study completion | Number of patients enrolled on study who continue to receive clinical benefit, up to 5 years | Number of patients enrolled who received seclidemstat |
| 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 the safety and tolerability of seclidemstat by characterizing adverse events according to the most current version of CTCAE |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess PK profile, maximum plasma concentration (Cmax) | During treatment while on study and continuing to receive clinical benefit, up to 5 years | • To assess pharmacokinetics of seclidemstat and metabolites in post-treatment tumor biopsies to compare partitioning of these analytes between tumor and plasma |
Countries
United States
Outcome results
None listed