This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V600E.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Vemurafenib 960 mg BID
Arizona Cancer Center
Tucson, Arizona, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Best Objective Response Rate (BORR)
BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants whose best overall response was a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a \>/=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper-Pearson.
Time frame: Up to 42 months
Time to BORR
In participants with a confirmed CR or PR, time to BORR was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occurred first). BORR was assessed by the investigators according to RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a \>/=30% decrease under baseline of the sum of diameters of all target lesions. Participants without confirmed CR or PR were censored at the date of last tumor assessment. The time to response was summarized using univariate statistics.
Time frame: From start of treatment up to first documentation of confirmed CR or PR (up to 42 months)
Duration of Response
In participants with a confirmed CR or PR, duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a \>/=30% decrease under baseline of the sum of diameters of all target lesions. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Duration of response was summarized using Kaplan-Meier method.
Time frame: From date of earliest qualifying response up to date of disease progression or death (up to 42 months)
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UCLA School of Medicine; Hematology/Oncology
Los Angeles, California, United States
The Angeles Clinic and Research Institute, Santa Monica Office
Santa Monica, California, United States
University of Colorado; Anschutz Cancer Pavilion
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University; Winship Cancer Institute
Atlanta, Georgia, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Atlantic Health System
Morristown, New Jersey, United States
...and 5 more locations
Progression-free Survival (PFS)
PFS was assessed by the investigators according to RECIST v1.1 and defined as the time interval between the date of the first treatment dose and the date of disease progression or death due to any cause, whichever occurred first. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. PFS was summarized using Kaplan-Meier method.
Time frame: From start of treatment up to first documentation of disease progression or death (up to 42 months)
Overall Survival (OS)
OS was defined as the time from the date of first treatment to the date of death due to any cause. OS was summarized using Kaplan-Meier method.
Time frame: Date of first treatment to date of death due to any cause (up to 42 months)
Percentage of Participants With 6-Month Survival
Time frame: Baseline to Month 6
Percentage of Participants With 12-Month Survival
Time frame: Baseline to Month 12
Number of Participants With an Adverse Event (AE)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.
Time frame: Up to 42 months