Clinical trial · Interventional
A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor Vemurafenib in Patients With Metastatic or Unresectable Papillary Thyroid Cancer (PTC) Positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tyrosine Kinase Inhibitor (TKI) Naive
- description
- Vemurafenib in participants naive to any prior systemic TKI therapy.
- interventionNames
- Drug: Vemurafenib
- type
- EXPERIMENTAL
- label
- TKI Experienced
- description
- Vemurafenib in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
- interventionNames
- Drug: Vemurafenib
Primary outcomes (1)
- measure
- Best Overall Response Rate in TKI-Naive Participants
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult participants. \>/= 18 years of age * Histologically confirmed metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective; participants whose tumors exhibit areas of "other histology" may be enrolled, provided the tumor histology remains predominantly papillary * Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test) * Radioactive Iodine resistant disease * Prior therapy excluding (Cohort 1, TKI Naive) or including (Cohort 2, TKI Experienced) TKI * Clinically relevant disease progression according to RECIST criteria within the prior 14 months * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate hematological, renal and liver function Exclusion Criteria: * Histological diagnosis other than papillary PTC, including squamous cell variants of PTC or PTC with areas of squamous metaplasia * Active or untreated central nervous system metastases * History of or known carcinomatous meningitis * Anticipated or ongoing administration of any anti-cancer therapies other than those administered in the study * Active squamous cell skin cancer that has not been excised or adequately healed post excision * Previous treatment with any agent that specifically and selectively targets the MEK or BRAF pathway * Prior radiotherapy to the only measurable lesion * Clinically relevant cardio-vascular disease or event within the prior 6 months
References
Publications (1)
- DERIVEDBrose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. doi: 10.1016/S1470-2045(16)30166-8. Epub 2016 Jul 23. PMID 27460442