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NCT04462471 · ClinicalTrials.gov registry record · Phase 1
Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04462471: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04462471 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04462471, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this study is to develop a new drug treatment to reverse tumor resistance to radioiodine in BRAF mutant tumors so that radioiodine can be given to shrink tumors. This study is also being done to find out the highest doses of copanlisib and vemurafenib that, when given in combination, do not cause serious side effects, and whether the study treatment will make radioiodine therapy work better in patients with BRAF-mutant thyroid cancers.
Primary Outcome
The primary objective of this study is to determine the MTD of vemurafenib plus copanlisib inpatients with advanced BRAF mutant RAIR thyroid cancer. The MTD is defined as the highest dose at which no more than 1 of 6 patients treated at that dose experience a DLT.
Interventions
- DRUG Vemurafenib
- DRUG Copanlisib
- DIAGNOSTIC_TEST I-124 PET/CT lesion dosimetry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-06-26 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 1 |
What the finished NCT04462471 record still lists
NCT04462471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Vemurafenib is the first listed.
NCT04462471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04462471 about?
NCT04462471 is a clinical study titled "Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers". The purpose of this study is to develop a new drug treatment to reverse tumor resistance to radioiodine in BRAF mutant tumors so that radioiodine can be given to shrink tumors. This study is also being done to find out the highest doses of copanlisib and vemurafenib that, when given in combination, ...
What is the current status of trial NCT04462471?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2020-06-26. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT04462471?
The interventions under investigation include: Vemurafenib (DRUG), Copanlisib (DRUG), I-124 PET/CT lesion dosimetry (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04462471?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04462471's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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