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NCT02098538 · ClinicalTrials.gov registry record · Phase 2
Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
A Phase 2 study of Adenoid Cystic Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 5
- Study locations
NCT02098538: Completed Phase 2 study of Adenoid Cystic Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02098538 is a Phase 2 study of Adenoid Cystic Carcinoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 38 participants, below the 126-participant average among 16 other Adenoid Cystic Carcinoma trials with a reported enrollment target (70% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02098538, a Phase 2 study of Adenoid Cystic Carcinoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 5
- Study locations
Study Summary
Regorafenib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if regorafenib is a useful drug for treating patients with adenoid cystic carcinomas. Regorafenib has been approved by the Food and Drug Administration (FDA) for use in other cancers, but remains an experimental drug that has not yet been approved for use in adenoid cystic carcinoma. In this study, the patient will initially be treated with a dose of regorafenib that is lower than what the FDA approved for other cancers in an attempt to decrease the risk of side effects. It is possible that this lower starting dose may not be as effective as the higher FDA approved dose. If the patient does well with the lower dose for at least a month on treatment, the physician may consider increasing the dose to the FDA approved dose.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Conditions Studied
Interventions
- DRUG Regorafenib
Study Locations (5)
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering at Mercy Medical Center - Rockville Centre
New Jersey
- Memorial Sloan Kettering Cancer Center - Basking Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2014-03 |
| Est. Completion | 2024-11-07 |
| Phase | Phase 2 |
What the finished NCT02098538 record still lists
NCT02098538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 126-participant average among 16 other Adenoid Cystic Carcinoma trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Adenoid Cystic Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Regorafenib is the first listed.
NCT02098538 lists 5 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02098538 about?
NCT02098538 is a clinical study titled "Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma". Regorafenib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if regorafenib is a useful drug for treating patients with adenoid cystic carcinomas. Regorafenib has been approved by the Food and Drug Ad...
What is the current status of trial NCT02098538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2014-03. Estimated completion is 2024-11-07.
What conditions does trial NCT02098538 study?
This clinical trial studies the following conditions: Adenoid Cystic Carcinoma.
What interventions are being tested in trial NCT02098538?
The interventions under investigation include: Regorafenib (DRUG).
Who is sponsoring clinical trial NCT02098538?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02098538 being conducted?
This trial has 5 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02098538's enrollment target sits among peer trials
38 9th of 16 higher than 8 of 16 other Adenoid Cystic Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adenoid Cystic Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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