Melanoma
Conditions
Keywords
Vemurafenib, skin cancer, Stage IV, advanced stage III, 11-091
Brief summary
The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on the patient and the melanoma. Specifically, the investigators want to know how well vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib can improve how well the patient functions.
Interventions
DRUGvemurafenib
All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Sponsors
Genentech, Inc.
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years old. * Histologic proof of melanoma reviewed and confirmed by MSKCC. * A confirmed EBRAFV600E or KBRAFV600K mutation. * Stage IV melanoma, or advanced stage III not curable by surgery. Patients with active CNS metastases will be allowed on the study. * Measurable disease by RECIST v1.1. * ECOG performance status 3 or 4. The basis for the grading of performance is strict; there must be clear justification of the performance status grade (e.g. patient is confined to bed \> 50% of time, or cannot carry out ADLs, or is otherwise disabled by burden of disease such as requiring supplemental O2). * Patients must be able to swallow pills * Adequate hematologic, hepatic and renal function as defined by the following: * Absolute Neutrophil Count ≥ 1.0 x 109/L * Hemoglobin ≥8.0g/dL, occasional transfusions are acceptable as vemurafenib does not have significant hematologic toxicities. * Total bilirubin ≤2.0x the upper limit of normal, ≤3.0x the upper limit of normal if the patient has Gilbert's Syndrome. * Alkaline phosphatase ≤2.0x the upper limit of normal. * AST and ALT ≤2.0x the upper limit of normal. * Serum creatinine ≤ 1.5x the upper limit of normal.
Exclusion criteria
* Uveal melanoma as primary. * Concurrent chemotherapy, immunotherapy, or radiotherapy. * Prior treatment with a RAF inhibitor. Other prior chemotherapy, immunotherapy, or radiotherapy will be allowed including prior treatment with a MEK inhibitor Patients must have had complete recovery from any adverse events or toxicities of prior cancer-directed therapies. * Pregnant or lactating women. * A second active malignancy. Prior malignancy will be allowed as long as the patient is known to be free of disease for at least 2 years. Patients with indolent B-cell malignancies will not be eligible. * QTc interval \> 500 msec.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Objective Response | 2 years | The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced. |
Countries
United States
Participant flow
Recruitment details
Protocol Open to Accrual: 11/15/2011 Protocol Closed to Accrual: 03/12/2013 Primary Completion Date (if applicable): 03/12/2013 Recruitment Location is the medical clinic
Participants by arm
| Arm | Count |
|---|---|
| Vemurafenib This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.
Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Vemurafenib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Overall Objective Response
The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vemurafenib | Overall Objective Response | Stable Disease | 1 participants |
| Vemurafenib | Overall Objective Response | Complete Response | 0 participants |
| Vemurafenib | Overall Objective Response | Partial Response | 0 participants |
| Vemurafenib | Overall Objective Response | Progression of Disease | 0 participants |