Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E



Status:Terminated
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:16 - Any
Updated:5/6/2016
Start Date:October 2011
End Date:April 2015

Use our guide to learn which trials are right for you!

An Open-Label, Multicenter, Phase II Study Of Continuous Oral Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf
(vemurafenib) in patients with locally-advanced, unresectable, stage IIIc or metastatic
melanoma and activating exon 15 BRAF mutations other than V600E.


Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

- Histologically-confirmed metastatic melanoma (unresectable Stage IIIc or IV) with an
activating BRAF mutation other than V600E

- Measurable disease (as defined by RECIST, v1.1)

- Adequate recovery from most recent systemic or local treatment for cancer

- Adequate organ function

- Women of childbearing potential and male partners of women of childbearing potential:
agreement to use prescribed contraception.

- Negative serum pregnancy test within 7 days of commencement of treatment in
premenopausal women. Women who are either surgically sterile or have been
post-menopausal for at least 1 year are eligible to participate in this study

- Agreement not to donate blood or blood products during the study and for at least 6
months after discontinuation of vemurafenib; for male patients, agreement not to
donate sperm during the study and for at least 6 months after discontinuation of
vemurafenib

Exclusion Criteria:

- Invasive malignancy other than melanoma at the time of enrollment and within 2 years
prior

- Pregnant or breast-feeding

- Concurrent anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation
therapy, including participation in an experimental drug study)

- Either a concurrent condition or history of a prior condition that places the patient
at unacceptable risk if he/she were treated with the study drug or confounds the
ability to interpret data from the study

- Ongoing cardiac dysrhythmia >/= Grade 2
We found this trial at
15
sites
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials