Trial record 1 of 1 for:    01667419
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BRIM8: A Study of Vemurafenib Adjuvant Therapy in Patients With Resected Cutaneous BRAF Mutant Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667419
First received: August 15, 2012
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be randomized to receive oral doses of vemurafenib 960 milligrams (mg) twice daily or matching placebo. The anticipated time on study treatment is 52 weeks.

Condition Intervention Phase
Malignant Melanoma
Drug: Placebo
Drug: Vemurafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF Mutant Melanoma at High Risk for Recurrence

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: Up to approximately 50 months (assessed every 13 weeks during study treatment, then every 26 to 52 weeks thereafter) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to approximately 6 years ] [ Designated as safety issue: No ]
  • Distant metastasis-free survival (DMFS) [ Time Frame: Up to approximately 50 months ] [ Designated as safety issue: No ]
  • Safety: Percentage of participants with adverse events [ Time Frame: Up to approximately 6 years ] [ Designated as safety issue: No ]
  • Quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) 30-item Quality of Life Questionnaire (QLQ-C30) score [ Time Frame: Days 1 and 15 of Cycles 1 and 2; Day 1 of Cycles 3 to 13; at end of treatment (up to 13 months); every 13 weeks thereafter until recurrence or new primary melanoma (up to approximately 50 months) ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Plasma concentration of vemurafenib [ Time Frame: Pre-morning dose and 1 to 4 hours post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose on Days 1 and 15 of Cycle 2; pre-morning dose on Day 1 of Cycles 3 to 13; at end of treatment (up to 13 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 475
Study Start Date: September 2012
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Arm
Participants will receive film-coated placebo tablets matched to vemurafenib, twice daily in 28-day cycles for up to 52 weeks.
Drug: Placebo
Participants will receive oral film-coated tablets matched to vemurafenib twice daily for 52 weeks.
Experimental: Vemurafenib Arm
Participants will receive film-coated vemurafenib tablets, 960 mg twice daily in 28-day cycles for up to 52 weeks.
Drug: Vemurafenib
Participants will receive oral vemurafenib 960 mg twice daily for 52 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed melanoma of cutaneous origin
  • Surgically rendered free of disease within 90 days of randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 5 years
  • Fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b
  • History of limb perfusion therapy
  • History of radiotherapy for the treatment of melanoma
  • Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first dose of study treatment
  • Family history of inherited colon cancer syndromes
  • History of clinically significant cardiac or pulmonary dysfunction
  • Major surgical procedure within 4 weeks prior to first dose of study treatment
  • Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
  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: NCT01667419

Contacts
Contact: Reference Study ID Number: GO27826 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 203 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667419     History of Changes
Other Study ID Numbers: GO27826  2011-004011-24 
Study First Received: August 15, 2012
Last Updated: January 7, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 23, 2016