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A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01286753•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (16)

Torrance, California, United States

New Haven, Connecticut, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Lyon, France

Key Dates

Start Date

June 1, 2011

Primary Completion Date

November 1, 2014

Completion Date

May 1, 2015

Last Updated

September 7, 2016

Enrollment

ACTUAL participants

Conditions

Neoplasms

Interventions

Vemurafenib

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITINGPHASE3

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

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