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Clinical Trials/EUCTR2010-024133-23-NL
EUCTR2010-024133-23-NLActive, not recruitingNot Applicable

An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine

F. Hoffman-La Roche Ltd.0 sites40 target enrollmentStarted: May 16, 2011Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
F. Hoffman-La Roche Ltd.

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