Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers (NCT04462471) | Clinical Trial Compass
CompletedPhase 1
Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers
United States8 participantsStarted 2020-06-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, and poorly differentiated subtypes and their respective variants).
* A tumor sample (primary, recurrent, or metastatic tumors) possessing a BRAF V600 mutation, as confirmed in a CLIA-certified laboratory or using an FDA-approved assay
* Measurable disease by RECIST v1.1 (tumors in previously irradiated fields may be considered measurable if there is evidence of tumor progression after radiation treatment)
* RAIR disease, as defined by any one of the following:
* A metastatic lesion that is not RAI-avid on a diagnostic radioiodine scan
* An RAI-avid lesion that remained stable in size or progressed despite RAI treatment before entry in this study (there are no size limitations for the index lesion used to satisfy this entry criterion)
* The presence of at least 1 FDG-avid lesion
* No receipt of treatment for thyroid cancer, defined as:
* No I-131 therapy \< 6 months before initiation of the protocol (time of initiation of the protocol is defined as the first day of drug therapy with vemurafenib and copanlisib); diagnostic activities of I-131 (0-10m Ci) are allowed within 6months of initiating the protocol
* No external beam radiation therapy \<4 weeks before initiation of the protocol
* No chemotherapy or targeted therapy including TKIs \<4 weeks (or \<5 half lives of the drug) before the initiation of this protocol
* Age of ≥ …
What they're measuring
1
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)