This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).
Highlands Oncology Group
Rogers, Arkansas, United States
UCLA Department of Medicine
Los Angeles, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
University of Chicago Medical Center; Medicine, Section of Pulmonary
Chicago, Illinois, United States
Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center
Sioux City, Iowa, United States
Dose Intensity of Vemurafenib
Dose Intensity was defined as (total actual doses taken/total planned doses) \*100, where total planned doses = prescribed doses \* planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.
Time frame: Baseline up to a maximum of 7 years.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. Reported are the Percentage of Participants with AEs and Serious Adverse Events (SAEs).
Time frame: Baseline up to 28 days after the last dose of study drug (up to a maximum of 7 years).
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
New York University Medical Center PRIME
New York, New York, United States
Evelyn H. Lauder Center
New York, New York, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Mary Crowley Medical Research Center; Oncology
Dallas, Texas, United States
...and 73 more locations