Trials / Completed
CompletedNCT04462471
Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers
A Phase Ib Trial of Vemurafenib Plus Copanlisib to Enhance Radioiodine Avidity in Radioiodine-Refractory Thyroid Cancers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Thyroid Carcinoma
- Thyroid Cancer
- Thyroid Cancer, Follicular
- Thyroid Cancer (Follicular Cell)
- Thyroid Cancer, Papillary
- BRAF V600E Mutation Positive
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | I-124 PET/CT lesion dosimetry | I-124 PET/CT scans will be performed during this process to quantify baseline RAI avidity in index metastatic lesion(s) |
| DRUG | Vemurafenib | Dose level 1 \& 2: 960 mg PO bid Dose level -1: 720 mg PO bid Dose level -2: 480 mg PO bid |
| DRUG | Copanlisib | Dose level 2: 60 mg IV weekly Dose level 1, -1, -2: 45 mg IV weekly |
Timeline
- Start date
- 2020-06-26
- Primary completion
- 2023-09-29
- Completion
- 2023-09-29
- First posted
- 2020-07-08
- Last updated
- 2025-09-08
- Results posted
- 2025-02-28
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04462471. Inclusion in this directory is not an endorsement.