A Study of RO5185426 in Patients With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutatio

Conditions: Metastatic or unresectable papillary thyroid cancer positive for BRAFV600 mutation and resistant to radioactive iodine therapy
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 15.1Level: LLTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 100000004864

Registration Number: EUCTR2010-024133-23-NL

Lead Sponsor: F. Hoffman-La Roche Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Adult patients. >/= 18 years of age

- Metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective

- 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 with activity against VEGFR2

- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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