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NCT04661852 · ClinicalTrials.gov registry record · Phase 1
Cabozantinib With Topotecan-Cyclophosphamide
A Phase 1 study of Refractory Osteosarcoma and Relapsed Osteosarcoma, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT04661852: Completed Phase 1 study of Refractory Osteosarcoma and Relapsed Osteosarcoma, sponsored by Dana-Farber Cancer Institute.
NCT04661852 is a Phase 1 study of Refractory Osteosarcoma and Relapsed Osteosarcoma that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 12 participants, below the 36-participant average among 7 other Refractory Osteosarcoma trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04661852, a Phase 1 study of Refractory Osteosarcoma and Relapsed Osteosarcoma, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study is a clinical trial of a new combination of drugs as a possible treatment for relapsed/refractory Ewing sarcoma and/or osteosarcoma. * The names of the drugs are: * Cabozantinib * Topotecan * Cyclophosphamide * The names of the non-investigational supportive care drugs are: * Filgrastim, pegfilgrastim, or a related growth factor.
Primary Outcome
Combination of cabozantinib with cyclophosphamide and topotecan * If no Dose Limiting Toxicities occur during the first cycle for all three subjects, dose escalation to the next highest dose level will occur for the next three enrolling patients. * If one out of three patients experience a DLT during the first cycle of therapy, up to three additional subjects will then be enrolled at the same dose level for a total of six patients at this dose level. If two or more patients experience DLTs in t
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cabozantinib
- DRUG Topotecan
- DRUG Myeloid growth factor
Study Locations (2)
Massachusetts
- Boston Children's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-12-23 |
| Est. Completion | 2022-10-24 |
| Phase | Phase 1 |
What the finished NCT04661852 record still lists
NCT04661852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 36-participant average among 7 other Refractory Osteosarcoma trials with a reported enrollment target (67% lower).
The record links to 4 conditions, with Refractory Osteosarcoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04661852 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04661852 about?
NCT04661852 is a clinical study titled "Cabozantinib With Topotecan-Cyclophosphamide". This research study is a clinical trial of a new combination of drugs as a possible treatment for relapsed/refractory Ewing sarcoma and/or osteosarcoma. * The names of the drugs are: * Cabozantinib * Topotecan * Cyclophosphamide * The names of the non-investigational supportive care drugs ar...
What is the current status of trial NCT04661852?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-12-23. Estimated completion is 2022-10-24.
What conditions does trial NCT04661852 study?
This clinical trial studies the following conditions: Refractory Osteosarcoma, Relapsed Osteosarcoma, Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma.
What interventions are being tested in trial NCT04661852?
The interventions under investigation include: Cyclophosphamide (DRUG), Cabozantinib (DRUG), Topotecan (DRUG), Myeloid growth factor (DRUG).
Who is sponsoring clinical trial NCT04661852?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04661852 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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