A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases - Full Text View

Purpose

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in patients with metastatic melanoma who developed brain metastases. Patients may or may not have received prior treatment for metastatic melanoma with brain metastases (except treatment with BRAF or MEK inhibitors). Patients will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Condition	Intervention	Phase
Malignant Melanoma	Drug: vemurafenib	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, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Vemurafenib

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Best Overall Response Rate (BORR) in previously untreated brain metastases (assessed by Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST)) [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best Overall Response Rate in previously treated or untreated brain metastases (assessed by Independent Review Committee)\n [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Best Overall Response Rate in previously treated brain metastases (assessed by Independent Review Committee)\n [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Best Overall Response Rate outside of the brain (assessed by Independent Review Committee) [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Time to development of new brain metastases in responding patient [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Best Overall Response Rate in brain metastases and outside of the brain (assessed by Investigator) [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	July 2011
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single arm	Drug: vemurafenib 960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal

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
Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
Measurable brain metastases, treated or untreated
Patients may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
Patients may or may not have symptoms related to their brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma

Exclusion Criteria:

Increasing corticosteroid dose during the 7 days prior to first dose of study drug
Leptomeningeal involvement
Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
Concurrent administration of any anticancer therapies other than those administered in the study
Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy 2 weeks prior to first dose of study drug
Prior treatment with BRAF or MEK inhibitors
Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378975

Contacts

Contact: Please reference Study ID Number: MO25743 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 35 Study Locations

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:	NCT01378975 History of Changes
Other Study ID Numbers:	MO25743
Study First Received:	June 21, 2011
Last Updated:	May 13, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type

Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013