Status:
ACTIVE_NOT_RECRUITING
SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma
Lead Sponsor:
Sarcoma Oncology Research Center, LLC
Collaborating Sponsors:
Tyme, Inc
Conditions:
Sarcoma, Ewing
Sarcoma
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 t...
Detailed Description
This prospective, open-label, two stage, pilot phase 2 trial evaluates the efficacy and safety of SM-88 in two cohorts of patients: 1) as maintenance therapy following standard primary or palliative t...
Eligibility Criteria
Inclusion
- Key
- 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)
- Salvage cohort: Any number of prior treatments
- Maintenance treatment cohort only: Patient completed current line of treatment (systemic, surgery, radiation) prior to enrollment, without disease progression as compared to baseline AND has achieved at least one of the following
- CR in response to current second or third line treatment
- PR in response to current line of treatment (after at least 4 cycles, if treatment included systemic therapy)
- SD in response to current line of treatment (after at least 4 cycles, if treatment included systemic therapy)
- Measurable disease, except for patients in Cohort A who have achieved CR at the conclusion of current 2nd or 3rd line of treatment
- ECOG performance status 0-2
- Adequate organ function defined as all laboratory parameters ≤ Grade 2 NCI CTCAE criteria
- Patients must be able to swallow and retain whole capsules
- Key
Exclusion
- 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
- History of any drug allergies or significant adverse reactions to any of the components of SM-88
- History of light sensitive diseases for which methoxsalen would be contraindicated
- Current or anticipated treatment with a contraindicated medication
- Evidence of viral infections including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
Key Trial Info
Start Date :
January 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2028
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03778996
Start Date
January 3 2020
End Date
March 31 2028
Last Update
February 24 2025
Active Locations (1)
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1
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403