Clinical TrialID 6653
SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma
NCT03778996
Sarcoma, Ewing|Sarcoma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6653
- Evidence Id
- 6653
- Core Evidence Id
- 6653
- Source Clinical Trial Id
- 6639
- Herb2 Clinical Trial Id
- HBCT006639
- Nct Id
- NCT03778996
- Title
- SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma
- Status
- Active_Not_Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Sarcoma, Ewing|Sarcoma
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS)
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult, Older_Adult
- Enrollment
- 31
- Outcome Measure
- Overall Response Rate, Complete response (CR) + partial response (PR) as evaluated using RECIST 1.1, Every 3 months for up to 2 years|Stable Disease for at Least 3 Months, Stable disease (SD) as evaluated using RECIST 1.1, Every 3 months for up to 2 years|Progression Free Survival on Study of at Least 1.5 Times the Duration of PFS for the Last Prior Treatment, From date of enrollment until the date of first documented progression, as evaluated using RECIST 1.1, or date of death, whichever occurs first, Every 3 months for up to 2 years
- Sponsor Collaborator
- Sarcoma Oncology Research Center, LLC|Tyme, Inc
- Funded By
- OTHER
- Location
- Sarcoma Oncology Research Center, Santa Monica, California, 90403, United States
- Other Id
- SM-88-JAF-16
- Start Date
- 2020-01-03
- Primary Completion Date
- 2024-12-19
- Completion Date
- 2025-03-31
- First Posted
- 2018-12-19
- Results First Posted
- Last Update Posted
- 2024-04-18
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT03778996
- Title Cn
- Title En
- SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma
- Bilingual Status
- semi_complete