Ewing SarcomaPhase 1NCT03600649
Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas
A Phase 1 study testing Seclidemstat, Cyclophosphamide and Topotecan in people with Ewing Sarcoma and Myxoid Liposarcoma, run by Salarius Pharmaceuticals, LLC at 16 sites in United States.
Trial summary
Single agent, non-randomized, open label expansion in select sarcoma patients including myxoid liposarcoma and other sarcomas that share similar chromosomal translocations to Ewing sarcoma; AND dose expansion of the combination of seclidemstat with topotecan and cyclophosphamide in patients with Ewing sarcoma Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ewing Sarcoma, Myxoid Liposarcoma, Sarcoma,Soft Tissue
- What is being tested?
- Seclidemstat, Cyclophosphamide and Topotecan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 16 sitesUnited States
- Study dates
- 4 Jun 2018to Dec 2025
- Phase
- Phase 1
- 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
- Age ≥ 12 years and weight ≥ 40 kg.
- Karnofsky ≥ 70% for over ≥ 16 years old and Lansky ≥ 70% for under 16 years old, equivalent to Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.
- Life expectancy of greater than 4 months in investigator's opinion.
- Willingness to provide tumor biopsies during screening and while on treatment. Optional for patients < 18 years of age and patients enrolled in the Ewing sarcoma combination treatment arm. Biopsies can be exempt if deemed by the investigator that the biopsy is not medically feasible for the patient or the patient is unfit for the procedure.
- Normal organ and marrow function as defined below:
- absolute neutrophil count (ANC) ≥ 1.5 x 109/L
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- platelets ≥ 100 x 109/L; no transfusion 7 days prior to labs
- total bilirubin ≤ 1.5 x upper limit of normal (ULN) or, in patients with Gilbert syndrome, total bilirubin > 1.5 x ULN as long as direct bilirubin is normal
- AST and ALT ≤ 3 x ULN
- creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above normal
- Ability to understand and the willingness to sign a written informed consent document.
- Additional Inclusion Criteria for Ewing Sarcoma Combination Treatment Cohort
- Patients must have a histologic confirmed diagnosis of Ewing sarcoma with a known EWSR1 translocation through local assessment that is relapsed or refractory and must have received at least one prior course of therapy for Ewing sarcoma. For the purposes of this study, refractory disease is defined as metastatic or unresectable disease that has either progressed or is stable at completion of planned therapy.
- Patients must have had no more than 2 lines/courses of systemic treatment for Ewing sarcoma
- No prior therapy with the combination regimen of topotecan and cyclophosphamide. Prior cyclophosphamide is allowed if not combined with topotecan.
- Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Additional Inclusion Criteria for Single Agent Myxoid Liposarcoma Cohort and for Single Agent FET-Translocated Sarcomas
- Patients must have a histologic confirmed diagnosis of one of the following sarcomas that share similar known chromosomal translocations to Ewing sarcoma (per local assessment) and are relapsed or refractory and not amenable to surgery at time of enrollment.
- Patients must have received at least one prior course of systemic therapy but no more than 3 courses of systemic therapy for sarcoma.
- Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Who cannot join
- Patients who have not recovered to Grade 1 or baseline from adverse events related to prior therapy excluding lymphopenia, alopecia, peripheral neuropathy and ototoxicity, which are only exclusionary if original AE was ≥ CTCAE Grade 3.
- Patients receiving therapy with other anti-neoplastic or experimental agents.
- Prior therapy with LSD1 targeted agents including monoamine oxidases for cancer therapy.
- Prior oral tyrosine kinase inhibitors (i.e. sorafenib, pazopanib, regorafenib, cabozantanib) within 14 days of Cycle 1 Day 1.
- Other, prior systemic anti-cancer treatment (chemotherapy or biologic therapy [i.e. monoclonal antibodies]) within 21 days prior to Cycle 1 Day 1. For agents that have known adverse events occurring beyond 21 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Medical Monitor.
- Prior therapy with immunotherapy such as a checkpoint inhibitor, cellular therapy or vaccine therapy within 28 days prior to Cycle 1 Day 1. Patients must have recovered from any immune-related adverse events to Grade 1 or baseline and require ≤ 10 mg of prednisone equivalent daily. Patients with immune-related hypothyroidism and/or hypoadrenalism may enroll while on thyroid or hydrocortisone replacement therapy, respectively.
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- Prior small port palliative radiotherapy within 14 days of Cycle 1 Day 1 or within 42 days of Cycle 1 Day 1 from definitive local control radiation (any dose greater than 50 Gy, within 42 days of Cycle 1 Day 1).
- Prior therapy with long acting myeloid growth factor within 14 days of Cycle 1 Day 1 or within 7 days of Cycle 1 Day 1 from a short acting myeloid growth factor.
- Evidence of graft versus host disease or prior allo- or auto-bone marrow transplant or stem cell infusion within 84 days from Cycle 1 Day 1 or receiving immunosuppressants following a stem cell procedure.
- Participation in a prior investigational study within 30 days prior to Cycle 1 Day 1 or within 5 half-lives of the investigational product, whichever is longer.
- Progressive or symptomatic brain metastases; patients with brain metastases may be included in this trial as long as the brain metastases have received definitive treatment and are stable (i.e., no evidence of progression). The brain metastases must be stable for a minimum of 6 weeks prior to Cycle 1 Day 1.
- Currently receiving any of the following substances and cannot be discontinued 14 days or 5 half-lives for CYP inhibitors (whichever is shorter) prior to Cycle 1 Day 1:
- moderate or strong inhibitors or inducers of major CYP isoenzymes, including grapefruit, grapefruit hybrids, pomelos, star fruit, and Seville oranges
- moderate or strong inhibitors or inducers of major drug transporters
- substrates of CYP3A4/5 with a narrow therapeutic index
- Uncontrolled concurrent illness including, but not limited to:
- ongoing or active infection
- transfusion dependent thrombocytopenia or anemia
- psychiatric illness/social situations that would limit compliance with study requirements; discuss with Medical Monitor if there are any questions
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
- symptomatic congestive heart failure
- left ventricular ejection fraction (LVEF) ≤ 50%
- unstable angina pectoris or cardiac arrhythmia
- baseline QTc (Fridericia) ≥ 450 milliseconds
- long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome
- Any major surgery within 21 days prior to Cycle 1 Day 1. Major surgery is defined as any significantly invasive procedure into a major body cavity (abdomen, cranium etc.) and/or surgery requiring extensive recuperation (joint replacement). Please discuss with Medical Monitor if there are any questions.
- 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.
- 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.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with seclidemstat. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
Virginia Cancer Specialists
Fairfax, Virginia, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Children's Hospital Los Angeles
Los Angeles, California, 90027
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health Sciences University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Sarcoma Oncology Research Center
Santa Monica, California, 90403
University of Washington
Seattle, Washington, 98109
Washington University
St Louis, Missouri, 63110
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase 1 Trial of the LSD1 Inhibitor Seclidemstat (SP 2577) With and Without Topotecan and Cyclophosphamide in Patients With Relapsed or Refractory Ewing Sarcoma and Select Sarcomas
Single agent, non-randomized, open label expansion in select sarcoma patients including myxoid liposarcoma and other sarcomas that share similar chromosomal translocations to Ewing sarcoma; AND dose expansion of the combination of seclidemstat with topotecan and cyclophosphamide in patients with Ewing sarcoma
Read the detailed description
The single agent expansion cohort of select sarcoma patients will enroll myxoid liposarcoma patients and patients with other sarcomas that share similar chromosomal translocations to Ewing sarcoma (FET-family translocations), including but not limited to desmoplastic small round cell tumor.
A safety lead-in dose escalation and dose expansion will be conducted assessing the combination of seclidemstat with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma.
- Conditions
- Ewing Sarcoma, Myxoid Liposarcoma, Sarcoma,Soft Tissue, Desmoplastic Small Round Cell Tumor, Extraskeletal Myxoid Chondrosarcoma, Angiomatoid Fibrous Histiocytoma
- Being tested
- Seclidemstat, Cyclophosphamide, Topotecan
- Medical subject headings
- Sarcoma, Ewing, Liposarcoma, Myxoid, Sarcoma, 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 LSD1 Inhibitor, SP-2577
Twice daily administration of seclidemstat
CyclophosphamideDrug
250 mg/m2/day on Days 1 thru 5 of a 21-day cycle
TopotecanDrug
0.75 mg/m2/day on Days 1 thru 5 of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Myxoid Liposarcoma | Experimental | Twice-daily administration of oral seclidemstat Receives: Drug: Seclidemstat |
| Sarcomas with FET-family translocations, including demoplastic small round cell tumors | Experimental | Twice-daily administration of oral seclidemstat Receives: Drug: Seclidemstat |
| Ewing sarcoma, combination therapy | Experimental | Twice daily administration of seclidemstat in combination with cyclophosphamide and topotecan Receives: Drug: Seclidemstat; Drug: Cyclophosphamide; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide measured by dose limiting toxicities and adverse events according to CTCAE version 5.0
To evaluate the safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma and select sarcomas. Toxicities will be graded in severity per the guidelines outlined in the NCI CTCAE version 5.0. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity.
Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months
Secondary outcomes (7)
Determine the maximum tolerated dose of SP-2577 as determined by dose limiting toxicities measured according to CTCAE version 5.0
To determine the maximum tolerated dose (MTD) of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma. Toxicities will be graded in severity per the guidelines outlined in the NCI CTCAE version 5.0. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity.
Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months
Characterization of the pharmacokinetics of SP-2577 as measured by peak plasma concentration
To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide.
Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months
Characterization of the pharmacokinetics of SP-2577 as measured by area under the curve
To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide.
Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months
Characterization of the pharmacokinetics of SP-2577 as measured by apparent clearance of seclidemstat
To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide.
Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months
Characterization of the pharmacokinetics of SP-2577 as measured by median half-life
To characterize pharmacokinetics of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide.
Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months
Food effects on the pharmacokinetics of SP-2577 as measured in both fasted and fed populations, primarily measured by apparent clearance.
To evaluate the effect of food on the pharmacokinetics of seclidemstat. Both fasted and fed PK samples will be taken.
Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months
Anti-tumor activity as measured according to RECIST 1.1 criteria based upon radiological assessments.
To evaluate the anti-tumor activity of seclidemstat as a single agent and in combination with topotecan and cyclophosphamide. Tumor response will be measured according to RECIST 1.1 criteria. Radiological assessments may be centrally collected and subjected to quality checks and review by a central imaging vendor at the discretion of Salarius.
Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start4 Jun 2018
- Primary completionSep 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two cohorts with single-agent seclidemstat in patients with myxoid liposarcoma and in patients with other sarcomas with similar chromosomal translocations to Ewing sarcoma (FET-family translocations), and one cohort of Ewing sarcoma patients treated with seclidemstat in combination with topotecan and cyclophosphamide
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salarius Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Pediatric Cancer Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600649
- Sponsor's protocol ID
- SALA-002-EW16
- Status last verified
- Nov 2023
- First submitted
- 4 Jun 2018
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of the LSD1 Inhibitor Seclidemstat (SP 2577) With and Without Topotecan and Cyclophosphamide in Patients With Relapsed or Refractory Ewing Sarcoma and Select Sarcomas
- ClinicalTrials.gov ID
- NCT03600649
- Acronym / sponsor ID
- SALA-002-EW16
- Conditions
- Ewing Sarcoma, Myxoid Liposarcoma, Sarcoma,Soft Tissue, Desmoplastic Small Round Cell Tumor, Extraskeletal Myxoid Chondrosarcoma, Angiomatoid Fibrous Histiocytoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Salarius Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Pediatric Cancer Foundation
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jul 2018 (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.
Single agent, non-randomized, open label expansion in select sarcoma patients including myxoid liposarcoma and other sarcomas that share similar chromosomal translocations to Ewing sarcoma; AND dose expansion of the combination of seclidemstat with topotecan and cyclophosphamide in patients with Ewing sarcoma
Detailed description
The single agent expansion cohort of select sarcoma patients will enroll myxoid liposarcoma patients and patients with other sarcomas that share similar chromosomal translocations to Ewing sarcoma (FET-family translocations), including but not limited to desmoplastic small round cell tumor.
A safety lead-in dose escalation and dose expansion will be conducted assessing the combination of seclidemstat with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two cohorts with single-agent seclidemstat in patients with myxoid liposarcoma and in patients with other sarcomas with similar chromosomal translocations to Ewing sarcoma (FET-family translocations), and one cohort of Ewing sarcoma patients treated with seclidemstat in combination with topotecan and cyclophosphamide
| Arm | Type | Receives |
|---|---|---|
| Myxoid Liposarcoma | Experimental | Drug: SeclidemstatTwice-daily administration of oral seclidemstat |
| Sarcomas with FET-family translocations, including demoplastic small round cell tumors | Experimental | Drug: SeclidemstatTwice-daily administration of oral seclidemstat |
| Ewing sarcoma, combination therapy | Experimental | Drug: Seclidemstat, Drug: Cyclophosphamide, Drug: TopotecanTwice daily administration of seclidemstat in combination with cyclophosphamide and topotecan |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 12 years and weight ≥ 40 kg.
- Karnofsky ≥ 70% for over ≥ 16 years old and Lansky ≥ 70% for under 16 years old, equivalent to Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.
- Life expectancy of greater than 4 months in investigator's opinion.
- Willingness to provide tumor biopsies during screening and while on treatment. Optional for patients < 18 years of age and patients enrolled in the Ewing sarcoma combination treatment arm. Biopsies can be exempt if deemed by the investigator that the biopsy is not medically feasible for the patient or the patient is unfit for the procedure.
- Normal organ and marrow function as defined below:
Key exclusion criteria (29 listed)
- Patients who have not recovered to Grade 1 or baseline from adverse events related to prior therapy excluding lymphopenia, alopecia, peripheral neuropathy and ototoxicity, which are only exclusionary if original AE was ≥ CTCAE Grade 3.
- Patients receiving therapy with other anti-neoplastic or experimental agents.
- Prior therapy with LSD1 targeted agents including monoamine oxidases for cancer therapy.
- Prior oral tyrosine kinase inhibitors (i.e. sorafenib, pazopanib, regorafenib, cabozantanib) within 14 days of Cycle 1 Day 1.
- Other, prior systemic anti-cancer treatment (chemotherapy or biologic therapy [i.e. monoclonal antibodies]) within 21 days prior to Cycle 1 Day 1. For agents that have known adverse events occurring beyond 21 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Medical Monitor.
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: LSD1 Inhibitor, SP-2577Twice daily administration of seclidemstat | Drug | Ewing sarcoma, combination therapy, Myxoid Liposarcoma, Sarcomas with FET-family translocations, including demoplastic small round cell tumors |
| Cyclophosphamide250 mg/m2/day on Days 1 thru 5 of a 21-day cycle | Drug | Ewing sarcoma, combination therapy |
| Topotecan0.75 mg/m2/day on Days 1 thru 5 of a 21-day cycle | Drug | Ewing sarcoma, combination therapy |
Primary outcome
Safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide measured by dose limiting toxicities and adverse events according to CTCAE version 5.0
Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
To evaluate the safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma and select sarcomas. Toxicities will be graded in severity per the guidelines outlined in the NCI CTCAE version 5.0. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity.
7 secondary outcomes
Determine the maximum tolerated dose of SP-2577 as determined by dose limiting toxicities measured according to CTCAE version 5.0
Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
Characterization of the pharmacokinetics of SP-2577 as measured by peak plasma concentration
Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
Characterization of the pharmacokinetics of SP-2577 as measured by area under the curve
Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
Characterization of the pharmacokinetics of SP-2577 as measured by apparent clearance of seclidemstat
Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
Characterization of the pharmacokinetics of SP-2577 as measured by median half-life
Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
Food effects on the pharmacokinetics of SP-2577 as measured in both fasted and fed populations, primarily measured by apparent clearance.
Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
Anti-tumor activity as measured according to RECIST 1.1 criteria based upon radiological assessments.
Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seclidemstat, Cyclophosphamide and Topotecan in people with Ewing Sarcoma and Myxoid Liposarcoma, run by Salarius Pharmaceuticals, LLC at 16 sites 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 20 inclusion and 29 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 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.
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?
Safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide measured by dose limiting toxicities and adverse events according to CTCAE version 5.0 (time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months). 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 21 Nov 2023.