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An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases


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

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Trial Information

An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases


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

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 previously untreated brain metastases (assessed by Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST))

Outcome Time Frame:

Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)

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:

MO25743

NCT ID:

NCT01378975

Start Date:

July 2011

Completion Date:

December 2013

Related Keywords:

  • Malignant Melanoma
  • Melanoma
  • Neoplasm Metastasis

Name

Location

Alexandria, Minnesota  56308
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Denver, Colorado  
Boston, Massachusetts  
Charlotte, North Carolina  
Las Vegas, Nevada  89109