Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single agent | Experimental | Single agent seclidemstat, as assigned per parent protocol |
|
| TC Combination | Experimental | Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seclidemstat | Drug | Treatment assigned as per parent protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluate safety & tolerability utilizing the most current version of CTCAE |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| D018208 | Liposarcoma, Myxoid |
| D058405 | Desmoplastic Small Round Cell Tumor |
| C563195 | Chondrosarcoma, Extraskeletal Myxoid |
| C563181 | Histiocytoma, Angiomatoid Fibrous |
| D018227 | Sarcoma, Clear Cell |
| D009208 | Myoepithelioma |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D008080 | Liposarcoma |
| D018205 | Neoplasms, Adipose Tissue |
| D018193 | Neoplasms, Complex and Mixed |
Not provided
Not provided
| ID | Term |
|---|---|
| C000730038 | seclidemstat |
| D019772 | Topotecan |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided