Ewing SarcomaPhase 1/2NCT05266196
A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)
A Phase 1/2 study testing Seclidemstat in people with Ewing Sarcoma and Myxoid Liposarcoma, run by Salarius Pharmaceuticals, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ewing Sarcoma, Myxoid Liposarcoma, Desmoplastic Small Round Cell Tumor
- What is being tested?
- Seclidemstat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
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.
Read the 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.
- Conditions
- Ewing Sarcoma, Myxoid Liposarcoma, Desmoplastic Small Round Cell Tumor, Extraskeletal Myxoid Chondrosarcoma, Angiomatoid Fibrous Histiocytoma, Clear Cell Sarcoma
- Being tested
- Seclidemstat
- Medical subject headings
- Sarcoma, Ewing, Liposarcoma, Myxoid, Desmoplastic Small Round Cell Tumor, Chondrosarcoma, Extraskeletal Myxoid, Histiocytoma, Angiomatoid Fibrous, Sarcoma, Clear Cell, Myoepithelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeclidemstatDrug
Also called topotecan, cyclophosphamide
Treatment assigned as per parent protocol
| Study group | Role | What they receive |
|---|---|---|
| Single agent | Experimental | Single agent seclidemstat, as assigned per parent protocol Receives: Drug: Seclidemstat |
| TC Combination | Experimental | Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol Receives: Drug: Seclidemstat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time receiving study treatment
Length of time receiving treatment with seclidemstat as single agent or in combination with assigned parent protocol therapy
Measured: months on study where patients continue to receive clinical benefit, up to 5 years
Secondary outcomes (3)
Number of patients enrolled through study completion
Number of patients enrolled who received seclidemstat
Measured: 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
Measured: 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
Measured: During treatment while on study and continuing to receive clinical benefit, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start15 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salarius Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266196
- Sponsor's protocol ID
- SALA-004-RO21
- Status last verified
- Jul 2023
- First submitted
- 11 Nov 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)
- ClinicalTrials.gov ID
- NCT05266196
- Acronym / sponsor ID
- SALA-004-RO21
- Conditions
- Ewing Sarcoma, Myxoid Liposarcoma, Desmoplastic Small Round Cell Tumor, Extraskeletal Myxoid Chondrosarcoma, Angiomatoid Fibrous Histiocytoma, Clear Cell Sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Salarius Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single agent | Experimental | Drug: SeclidemstatSingle agent seclidemstat, as assigned per parent protocol |
| TC Combination | Experimental | Drug: SeclidemstatCombination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeclidemstatAlso: topotecan, cyclophosphamideTreatment assigned as per parent protocol | Drug | Single agent, TC Combination |
Primary outcome
Length of time receiving study treatment
Time frame: 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
3 secondary outcomes
Number of patients enrolled through study completion
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
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
Time frame: During treatment while on study and continuing to receive clinical benefit, up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Seclidemstat in people with Ewing Sarcoma and Myxoid Liposarcoma, run by Salarius Pharmaceuticals, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time receiving study treatment (time frame: months on study where patients continue to receive clinical benefit, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.