SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma (NCT03778996) | Clinical Trial Compass
Active — Not RecruitingPhase 2
SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma
United States31 participantsStarted 2020-01-03
Plain-language 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.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ability to understand and willingness to provide written informed consent to participate in this study
✓. ≥12 years of age
✓. Diagnosis:
✓. Maintenance treatment cohort: Histologic or cytologic diagnosis of Ewing's sarcoma, including non-resected, locally advanced or metastatic disease
✓. Salvage treatment cohort: Non-resected, locally advanced or metastatic sarcoma (including Ewing's sarcoma) for which there is no standard of care treatment and no curative other option
✓. Radiographic disease assessment within 35 days prior to enrollment and planned treatment start with study drug
✓. Prior treatment:
✓. Maintenance treatment cohort : 1-3 prior lines of systemic treatment (including current treatment)
Exclusion criteria
✕. Systemic anticancer agents within 14 days prior to treatment on study
✕. Major surgery within 30 days
✕. Prior treatment with SM-88
✕. Any screening laboratory, electrocardiogram (ECG), other clinical finding, comorbidity or clinical history that, in the opinion of the investigator, indicates an unacceptable risk for patient to participate in the study or would limit patient's ability to comply with study requirements
What they're measuring
1
Overall Response Rate
Timeframe: Every 3 months for up to 2 years
2
Stable Disease for at Least 3 Months
Timeframe: Every 3 months for up to 2 years
3
Progression Free Survival on Study of at Least 1.5 Times the Duration of PFS for the Last Prior Treatment