Enhancing Radioiodine Incorporation Into Radio Iodine Refractory Thyroid Cancers With MAPK Inhibition
- Sponsor
- University Hospital, Essen
- Study ID
- NCT04619316
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Metastatic Thyroid Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Trametinib 2 MG [Mekinist] — DRUGMonotherapy with Trametinib is given in patients with BRAF wildtype.
- Trametinib 2 MG [Mekinist] and Dabrafenib 75 MG (2-0-2) [Tafinlar] — DRUGCombination therapy is given in patients with BRAF V600E mutation.
Study Details
This is a prospective interventional trial that aims to restore iodine incorporation in tumoral lesions of patients with unresectable, radioiodine-refractory thyroid cancer.
Key Dates
- Start date
- Feb 5, 2018
- Status verified
- Jun 2023
- Primary completion
- Dec 31, 2024
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 70 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Other: BRAF wild typeIn BRAF wild type patients trametinib 2mg (1-0-0) is applied daily over a time span of 3 weeks, then the effect is evaluated via 123I whole-body scintigraphy
- Other: BRAF V600E MutationIn BRAF wild type patients trametinib 2mg (1-0-0) and dabrafenib 75mg (2-0-2) are applied daily over a time span of 3 weeks, then the effect is evaluated via 123I whole-body scintigraphy
Primary Outcome Measure
Proportion of patients with sufficiently increased tumoral iodine incorporation [ Time Frame: At the time point of 123I whole-body scintigraphy, 3 weeks after the start of redifferentiation therapy ]
Central Contacts
- Wolfgang P Fendler, MD+49 201 723 2032
- Manuel M Weber, MD+49 201 723 2032
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