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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01286753
First received: January 28, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This open-label, multi-center study will evaluate the safety and efficacy of RO5185426 in patients with metastatic or unresectable papillary thyroid cancer positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Patients will receive RO5185426 960 mg orally twice daily until progressive disease or unacceptable toxicity occurs.


Condition Intervention Phase
Neoplasms
Drug: RO5185426
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Best overall response rate (BORR) in tyrosine kinase inhibitor (TKI)-naïve patients (Cohort 1), assessed by the investigator according to RECIST criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical benefit rate (objective response rate + stable disease) in TKI-naïve patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of response in TKI-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival in TKI-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Overall survival in TKI-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Best overall response rate in TKI-exposed patients (Cohort 2) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Clinical benefit rate in TKI-exposed patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of response in TKI-exposed patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival in TKI-exposed patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Overall survival in TKI-exposed patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: up to 4.5 years ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: June 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: RO5185426
960 mg orally twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients. >/= 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; patients 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) or including (Cohort 2) tyrosine kinase inhibitor (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 thyroid carcinoma (PTC), including squamous cell variants of PTC or PTC with areas of squamous metaplasia
  • Active or untreated CNS 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286753

Locations
United States, California
Torrance, California, United States, 90502
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Maryland
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, New York
New York, New York, United States, 10065
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston, Texas, United States, 77030
France
Lyon, France, 69008
Paris, France, 75651
Villejuif, France, 94805
Italy
Milano, Lombardia, Italy, 20133
Pisa, Toscana, Italy, 56124
Netherlands
Groningen, Netherlands, 9713 GZ
Leiden, Netherlands, 2333 ZA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01286753     History of Changes
Other Study ID Numbers: NO25530, 2010-024133-23
Study First Received: January 28, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on April 23, 2014