Seclidemstat Access for Sarcoma

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Salarius Pharmaceuticals, LLC

Must be taking: Seclidemstat

Disqualifiers: Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial allows patients who have previously benefited from seclidemstat to continue their treatment. Seclidemstat is a drug that aims to stop cancer cells from growing by blocking essential proteins. The trial targets patients who are still seeing positive results.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that you cannot receive certain therapies that are not allowed in the parent protocol. It's best to discuss your current medications with the trial team to see if they are permitted.

How does the drug Seclidemstat differ from other treatments for sarcoma?

Seclidemstat is unique because it targets specific biological pathways involved in sarcoma, offering a personalized approach to treatment. Unlike standard chemotherapy, it may provide more tailored options for patients with rare sarcoma subtypes that lack standard treatments. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for patients who have been part of previous Salarius studies and are still benefiting from Seclidemstat, either alone or with other treatments. They must follow the study rules, use contraception if they can have children, and not be pregnant or breastfeeding. People can't join if they were taken off the original study treatment for any reason except to join this new one.

Inclusion Criteria

I am currently in a Salarius study and taking seclidemstat, with no more than a 14-day break between studies.

I am responding well to my current seclidemstat treatment.

I agree to use birth control during the study and will report any pregnancy immediately.

Exclusion Criteria

Pregnant and breastfeeding women

Patient permanently discontinued from parent study treatment for any reason other than entering this rollover study

Receiving prohibited concomitant therapy as described in the rollover protocol or therapy not allowed in the parent protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue to receive seclidemstat as a single agent or in combination with topotecan and cyclophosphamide, as assigned per parent protocol

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Seclidemstat

Trial Overview The trial provides ongoing access to Seclidemstat (SP-2577) for those already seeing positive effects from it in past trials by Salarius. It's a rollover protocol which means patients continue with the same medication without interruption.

Participant Groups

Group I: TC Combination Experimental Treatment 1 Intervention

Combination of seclidemstat with topotecan and cyclophosphamide, as assigned per parent protocol

Group II: Single agent Experimental Treatment 1 Intervention

Single agent seclidemstat, as assigned per parent protocol

Who Is Running the Clinical Trial?

Salarius Pharmaceuticals, LLC

Lead Sponsor

Trials

5

Recruited

160+

Findings from Research

In a study of 806 patients with localized soft tissue sarcoma, those who received perioperative chemotherapy had a 5-year metastasis-free survival rate of 58%, indicating that this treatment can be effective in real-world settings.

While the long-term outcomes of patients receiving perioperative chemotherapy in routine clinical practice were similar to those in clinical trials, there were notable risks of secondary malignancies and cardiac toxicity, highlighting the importance of considering these potential side effects in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence on perioperative chemotherapy in localized soft tissue sarcoma of the extremities and trunk wall; a population-based study. Boye, K., Lobmaier, I., Kobbeltvedt, MR., et al.[2022]

Using patient-derived tumor organoids (PDTOs) from 194 specimens of 126 sarcoma patients, researchers were able to identify effective treatment options for 59% of the cases, highlighting the potential of PDTOs in personalizing therapy for rare sarcoma subtypes.

The study demonstrated that drug sensitivity in PDTOs correlated with various clinical factors, such as tumor subtype and patient treatment history, suggesting that organoid drug screening can guide treatment decisions and improve patient outcomes in sarcoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The landscape of drug sensitivity and resistance in sarcoma. Al Shihabi, A., Tebon, PJ., Nguyen, HTL., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Real-world evidence on perioperative chemotherapy in localized soft tissue sarcoma of the extremities and trunk wall; a population-based study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The landscape of drug sensitivity and resistance in sarcoma. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321. [2023]

4. Egypt pubmed.ncbi.nlm.nih.gov

Deep Functional and Molecular Characterization of a High-Risk Undifferentiated Pleomorphic Sarcoma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

There is more to soft tissue sarcomas than just grade and size. [2022]