Trial · NCT04462471
Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers
NCT04462471, Phase 1, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2025-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers. Trials, record NCT04462471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04462471
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers
- NCT number
- NCT04462471
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Thyroid Carcinoma, Thyroid Cancer, Thyroid Cancer, Follicular, Thyroid Cancer (Follicular Cell), Thyroid Cancer, Papillary, BRAF V600E Mutation Positive
- Interventions
- I-124 PET/CT lesion dosimetry, Vemurafenib, Copanlisib
- First posted
- 2020-07-08
- Last updated
- 2025-09-08
- Results first posted
- 2025-02-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | 6 months | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | 6 months | Study closed to low accrual | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Dose Level 1 | Experienced DLT | 0 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Dose Level 2 | Experienced DLT | 0 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Dose Level -1 | Experienced DLT | 0 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Dose Level -2 | Experienced DLT | 0 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Dose Level 1 | Did not experience DLT | 4 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Dose Level 2 | Did not experience DLT | 4 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Dose Level -1 | Did not experience DLT | 0 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Dose Level -2 | Did not experience DLT | 0 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 | 4 | |
| Overall Study | STARTED | Dose Level 2 | 4 | |
| Overall Study | STARTED | Dose Level -1 | 0 | |
| Overall Study | STARTED | Dose Level -2 | 0 | |
| Overall Study | COMPLETED | Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Dose Level 2 | 3 | |
| Overall Study | COMPLETED | Dose Level -1 | 0 | |
| Overall Study | COMPLETED | Dose Level -2 | 0 | |
| Overall Study | NOT COMPLETED | Dose Level 1 | 1 | |
| Overall Study | NOT COMPLETED | Dose Level 2 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events172
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 1 | 1 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 2 | 0 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level -1 | 0 | ||
| other | Abdominal pain | Gastrointestinal disorders | Dose Level -2 | 0 | ||
| other | Alanine aminotransferase increased | Investigations | Dose Level 1 | 1 | 4 | |
| other | Alanine aminotransferase increased | Investigations | Dose Level 2 | 0 | 4 | |
| other | Alanine aminotransferase increased | Investigations | Dose Level -1 | 0 | ||
| other | Alanine aminotransferase increased | Investigations | Dose Level -2 | 0 | ||
| other | Alopecia | Skin and subcutaneous tissue disorders | Dose Level 1 | 1 | 4 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Dose Level 2 | 1 | 4 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 0 | 4 |
| Total, all-cause mortality | Dose Level 2 | 0 | 4 |
| Total, all-cause mortality | Dose Level -1 | 0 | 0 |
| Total, all-cause mortality | Dose Level -2 | 0 | 0 |
| Total, other adverse events | Dose Level 1 | 4 | 4 |
| Total, other adverse events | Dose Level 2 | 4 | 4 |
| Total, other adverse events | Dose Level -1 | 0 | 0 |
| Total, other adverse events | Dose Level -2 | 0 | 0 |
| Total, serious adverse events | Dose Level 1 | 1 | 4 |
| Total, serious adverse events | Dose Level 2 | 1 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37171634 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04462471
GET https://conductscience.org/api/trials/v1/NCT04462471/events?page=2