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: October 20, 2014
Last verified: October 2014

June 21, 2011
October 20, 2014
July 2011
April 2015   (final data collection date for primary 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)) [ Time Frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01378975 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases
An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Drug: vemurafenib
960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal
Experimental: Single arm
Intervention: Drug: vemurafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
146
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States,   United Kingdom,   Canada,   France,   Germany,   Israel,   Italy,   Netherlands,   Spain
 
NCT01378975
MO25743
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP