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NCT02048371 · ClinicalTrials.gov registry record · Phase 2
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
A Phase 2 study, sponsored by Sarcoma Alliance for Research through Collaboration.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT02048371 is a Phase 2 study that has completed, run by Sarcoma Alliance for Research through Collaboration. The registered enrollment target is 131 participants.
The verdict
NCT02048371, a Phase 2 study, has completed, sponsored by Sarcoma Alliance for Research through Collaboration.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study Summary
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.
Interventions
- DRUG Placebo
- DRUG Regorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2014-07 |
| Est. Completion | 2022-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02048371
The ClinicalTrials.gov registry entry for NCT02048371 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarcoma Alliance for Research through Collaboration, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02048371 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02048371 about?
NCT02048371 is a clinical study titled "SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes". Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazo...
What is the current status of trial NCT02048371?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2014-07. Estimated completion is 2022-05.
What interventions are being tested in trial NCT02048371?
The interventions under investigation include: Placebo (DRUG), Regorafenib (DRUG).
Who is sponsoring clinical trial NCT02048371?
This trial is sponsored by Sarcoma Alliance for Research through Collaboration, which has 20 total clinical trials registered on ClinicalTrials.gov.
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