A Study of RO5185426 (Vemurafenib) in Patients With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01286753
First received: January 28, 2011
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This open-label, multi-center study will evaluate the safety and efficacy of RO5185426 in patients with metastatic or unresectable papillary thyroid cancer positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Patients will receive RO5185426 960 mg orally twice daily until progressive disease or unacceptable toxicity occurs.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: RO5185426 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical benefit rate (objective response rate + stable disease) in TKI-naïve patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Duration of response in TKI-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Progression-free survival in TKI-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Overall survival in TKI-naïve patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Best overall response rate in TKI-exposed patients (Cohort 2) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Clinical benefit rate in TKI-exposed patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Duration of response in TKI-exposed patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Progression-free survival in TKI-exposed patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Overall survival in TKI-exposed patients [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: up to 4.5 years ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: RO5185426
960 mg orally twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286753
Locations
| United States, California | |
| Torrance, California, United States, 90502 | |
| United States, Connecticut | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| New York, New York, United States, 10065 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| France | |
| Lyon, France, 69008 | |
| Paris, France, 75651 | |
| Villejuif, France, 94805 | |
| Italy | |
| Milano, Italy, 20133 | |
| Pisa, Italy, 56124 | |
| Netherlands | |
| Groningen, Netherlands, 9713 GZ | |
| Leiden, Netherlands, 2333 ZA | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01286753 History of Changes |
| Other Study ID Numbers: | NO25530, 2010-024133-23 |
| Study First Received: | January 28, 2011 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Thyroid Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Endocrine System Diseases Thyroid Diseases |
ClinicalTrials.gov processed this record on June 17, 2013