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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best overall response rate (BORR) in tyrosine kinase inhibitor (TKI)-naïve patients (Cohort 1), assessed by the investigator according to RECIST criteria

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO25530

NCT ID:

NCT01286753

Start Date:

June 2011

Completion Date:

June 2015

Related Keywords:

  • Neoplasms
  • Neoplasms
  • Thyroid Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Fountain Valley, California  92708
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Baltimore, Maryland  21287
Boston, Massachusetts