A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
NCT ID: NCT01286753
Last Updated: 2016-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2011-06-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tyrosine Kinase Inhibitor (TKI) Naive
Vemurafenib in participants naive to any prior systemic TKI therapy.
Vemurafenib
Vemurafenib 960 mg orally twice daily.
TKI Experienced
Vemurafenib in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
Vemurafenib
Vemurafenib 960 mg orally twice daily.
Interventions
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Vemurafenib
Vemurafenib 960 mg orally twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Torrance, California, United States
New Haven, Connecticut, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Lyon, , France
Paris, , France
Villejuif, , France
Milan, Lombardy, Italy
Pisa, Tuscany, Italy
Groningen, , Netherlands
Leiden, , Netherlands
Countries
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References
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Brose 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.
Other Identifiers
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2010-024133-23
Identifier Type: -
Identifier Source: secondary_id
NO25530
Identifier Type: -
Identifier Source: org_study_id
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