A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378975
• Other study ID #: MO25743
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2011
• Last updated: April 2, 2016
• Start date: July 2011
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• vemurafenib
960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Israel,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response Rate (BORR) in previously untreated brain metastases (assessed by Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST))		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Best Overall Response Rate in previously treated or untreated brain metastases (assessed by Independent Review Committee)\n		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Best Overall Response Rate in previously treated brain metastases (assessed by Independent Review Committee)\n		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Safety: Incidence of adverse events		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Best Overall Response Rate outside of the brain (assessed by Independent Review Committee)		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Duration of response		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Progression-free survival		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Time to development of new brain metastases in responding patient		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Overall survival		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No
Secondary	Best Overall Response Rate in brain metastases and outside of the brain (assessed by Investigator)		Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)	No