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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01286753
Other study ID # NO25530
Secondary ID 2010-024133-23
Status Active, not recruiting
Phase Phase 2
First received January 28, 2011
Last updated November 24, 2014
Start date June 2011
Est. completion date October 2015

Study information

Verified date November 2014
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 51
Est. completion date October 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
RO5185426
960 mg orally twice daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France,  Italy,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best overall response rate (BORR) in tyrosine kinase inhibitor (TKI)-naïve patients (Cohort 1), assessed by the investigator according to RECIST criteria 18 months No
Secondary Clinical benefit rate (objective response rate + stable disease) in TKI-naïve patients 18 months No
Secondary Duration of response in TKI-naïve patients 4.5 years No
Secondary Progression-free survival in TKI-naïve patients 4.5 years No
Secondary Overall survival in TKI-naïve patients 4.5 years No
Secondary Best overall response rate in TKI-exposed patients (Cohort 2) 18 months No
Secondary Clinical benefit rate in TKI-exposed patients 18 months No
Secondary Duration of response in TKI-exposed patients 4.5 years No
Secondary Progression-free survival in TKI-exposed patients 4.5 years No
Secondary Overall survival in TKI-exposed patients 4.5 years No
Secondary Safety: Incidence of adverse events 4.5 years No
Secondary Pharmacokinetics: Area under the concentration-time curve (AUC) up to 4.5 years No
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