Overview

This trial is active, not recruiting.

Condition neoplasms
Treatment ro5185426
Phase phase 2
Target BRAF
Sponsor Hoffmann-La Roche
Start date June 2011
End date November 2014
Trial size 51 participants
Trial identifier NCT01286753, 2010-024133-23, NO25530

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ro5185426
960 mg orally twice daily

Primary Outcomes

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

Secondary Outcomes

Measure
Clinical benefit rate (objective response rate + stable disease) in TKI-naïve patients
time frame: 18 months
Duration of response in TKI-naïve patients
time frame: 4.5 years
Progression-free survival in TKI-naïve patients
time frame: 4.5 years
Overall survival in TKI-naïve patients
time frame: 4.5 years
Best overall response rate in TKI-exposed patients (Cohort 2)
time frame: 18 months
Clinical benefit rate in TKI-exposed patients
time frame: 18 months
Duration of response in TKI-exposed patients
time frame: 4.5 years
Progression-free survival in TKI-exposed patients
time frame: 4.5 years
Overall survival in TKI-exposed patients
time frame: 4.5 years
Safety: Incidence of adverse events
time frame: 4.5 years
Pharmacokinetics: Area under the concentration-time curve (AUC)
time frame: up to 4.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.