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 |
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.
(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
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