A Phase 1/2 interventional study of Seclidemstat in Ewing Sarcoma, Myxoid Liposarcoma and Desmoplastic Small Round Cell Tumor, sponsored by Salarius Pharmaceuticals, LLC. Enrolling by invitation at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Salarius Pharmaceuticals, LLC · Phase 1/2, Interventional, and Treatment
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.
250 studies on the registry are indexed under Sarcoma, Ewing; 69 are open to participants now.
This study's planned enrollment of 10 is below the median of 36 across 204 interventional studies indexed under Sarcoma, Ewing.
Browse Sarcoma, Ewing studies →Salarius Pharmaceuticals, LLC is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single agent seclidemstat, as assigned per parent protocol
Drug: Seclidemstat
Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol
Drug: Seclidemstat
Treatment assigned as per parent protocol
Also known as: topotecan, cyclophosphamide
Length of time receiving study treatment
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
Number of patients enrolled through study completion
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
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
Time frame: 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
Time frame: During treatment while on study and continuing to receive clinical benefit, up to 5 years
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
Time frame: During treatment while on study and continuing to receive clinical benefit, up to 5 years
Plan to share: No
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Studies of the drug tested here: Seclidemstat
Salarius Pharmaceuticals, LLC