A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01378975
First received: June 21, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This open-label, single-arm, multicenter study will evaluate the efficacy and sa fety in patients with metastatic melanoma who developed brain metastases. Patien ts may or may not have received prior treatment for metastatic melanoma with bra in metastases (except treatment with BRAF or MEK inhibitors). Patients will rece ive oral doses of 960 mg vemurafenib twice daily until disease progression, unac ceptable 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:


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 ]

Enrollment: 146
Study Start Date: July 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  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: July 21, 2014
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 July 29, 2014