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SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma

NCT03778996 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-02-24

No results posted yet for this study

Summary

The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, in two study cohorts:

* Clinically advanced Ewing's Sarcoma patients who have not progressed at the conclusion of systemic treatment
* Clinically advanced sarcoma patients in the salvage treatment setting

Up to 24 efficacy evaluable patients (up to 12 per cohort) will be enrolled. Study patients will receive oral SM-88, with scheduled safety and efficacy evaluations.

Conditions

  • Sarcoma, Ewing
  • Sarcoma

Interventions

DRUG

Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS)

Daily oral combination therapy for cancer

Sponsors & Collaborators

  • Tyme, Inc

    collaborator INDUSTRY

  • Sarcoma Oncology Research Center, LLC

    lead OTHER

Principal Investigators

  • Sant P Chawla, MD · Sarcoma Oncology Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2027-12-19
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03778996 on ClinicalTrials.gov