ZELBORAF (vemurafenib) is a kinase inhibitor available as 240 mg tablets for oral use.
ZELBORAF™ is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test.
Limitation of Use: ZELBORAF is not recommended for use in patients with wild-type BRAF melanoma.
Published Studies Related to Zelboraf (Vemurafenib)
A phase I, randomized, open-label study of the multiple-dose pharmacokinetics of
vemurafenib in patients with BRAF V600E mutation-positive metastatic melanoma. 
microprecipitated bulk powder film-coated tablets)... CONCLUSIONS: Vemurafenib plasma concentration accumulates with multiple bid doses
Vemurafenib for the treatment of locally advanced or metastatic BRAF V600
mutation-positive malignant melanoma: a NICE single technology appraisal. 
Vemurafenib is an oral BRAF inhibitor licenced for the treatment of locally
advanced or metastatic BRAF V600-mutation positive malignant melanoma. The
manufacturer of vemurafenib, Roche Products Limited, was invited by the National
Institute for Health and Care Excellence (NICE) to submit evidence of the drug's
clinical- and cost-effectiveness for its licenced indication, to inform the
Institute's Single Technology Appraisal (STA) process...
Vemurafenib and ipilimumab: new agents for metastatic melanoma. 
CONCLUSION: Vemurafenib and ipilimumab are important advances in the treatment of
Analysis of dermatologic events in vemurafenib-treated patients with melanoma. 
carcinoma (cuSCC)... CONCLUSIONS: Dermatologic AEs associated with vemurafenib treatment in patients
BRIM-1, -2 and -3 trials: improved survival with vemurafenib in metastatic
melanoma patients with a BRAF(V600E) mutation. 
Following Phase I and II studies revealing vemurafenib to be a safe potent
inhibitor of mutated BRAF in patients with metastatic melanoma, a multicenter
randomized Phase III trial was carried out to compare vemurafenib with
dacarbazine in treatment-naive patients.
Clinical Trials Related to Zelboraf (Vemurafenib)
Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E [Recruiting]
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.
A Study of The Safety and Pharmacology of MPDL3280A Administered in Combination With Vemurafenib (Zelboraf®) in Patients With Previously Untreated BRAFV600-Mutation Positive Metastatic Melanoma [Recruiting]
This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of
MPDL3280A in combination with Vemurafenib (Zelboraf®) in previously untreated patients with
BRAFV600-mutation positive metastatic melanoma.
Study of PX-866 and Vemurafenib in Patients With Advanced Melanoma [Recruiting]
The purpose of the phase 1 portion of the study is to determine the maximally tolerated dose
(MTD) or recommended dose (RD) and the safety/tolerability of PX-866 in combination
vemurafenib in patients with any advanced BRAF-mutant cancer.
The purpose of the phase 2 portion of the study is to compare progression free survival
(PFS), antitumor activity (response rate), disease control rate (DCR), and the safety and
tolerability of PX-866 in combination with vemurafenib vs. vemurafenib alone in patients
with advanced BRAF-mutant melanoma at the doses recommended from Phase 1.
An Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol [Not yet recruiting]
This open-label, multicenter, non-randomized study will provide continued access to
vemurafenib for eligible patients 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 are treated beyond progression and are still
deriving clinical benefit (as assessed by investigator), and may therefore potentially
benefit from continued treatment with vemurafenib. Patients will receive treatment with
vemurafenib 960 mg orally twice daily or, if the dose was reduced in an antecedent protocol,
the dose of the last visit of the antecedent study (minimum 480 mg orally twice daily).
Treatment will continue until progression of disease or as long as the patient is deriving
clinical benefit, as judged by the investigator, or until unacceptable toxicity occurs.
Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation [Recruiting]
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.
Reports of Suspected Zelboraf (Vemurafenib) Side Effects
Decreased Appetite (106),
Disease Progression (73),
Diarrhoea (66), more >>
Page last updated: 2014-12-01