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: August 4, 2014
Last verified: August 2014

January 28, 2011
August 4, 2014
June 2011
November 2014   (final data collection date for primary outcome measure)
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 ]
Best overall response rate (BORR) in sorafenib-naïve patients (Cohort 1), assessed by the investigator according to RECIST criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01286753 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinical benefit rate (objective response rate + stable disease) in sorafenib-naïve patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of response in sorafenib-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival in sorafenib-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Overall survival in sorafenib-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Best overall response rate in sorafenib-exposed patients (Cohort 2) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Clinical benefit rate in sorafenib-exposed patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of response in sorafenib-exposed patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival in sorafenib-exposed patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Overall survival in sorafenib-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 (Tmax, Cmax, Cmin, AUC) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of RO5185426 (Vemurafenib) in Patients 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

This open-label, multi-center study will evaluate the safety and efficacy of RO5 185426 in patients with metastatic or unresectable papillary thyroid cancer posi tive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Pat ients will receive RO5185426 960 mg orally twice daily until progressive disease or unacceptable toxicity occurs.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: RO5185426
960 mg orally twice daily
Experimental: Single Arm
Intervention: Drug: RO5185426
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
51
October 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Netherlands
 
NCT01286753
NO25530, 2010-024133-23
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP