DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Zelboraf (Vemurafenib) - Summary

 
 



ZELBORAF SUMMARY

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.


See all Zelboraf indications & dosage >>

NEWS HIGHLIGHTS

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. [2014]
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. [2013]
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. [2013]
CONCLUSION: Vemurafenib and ipilimumab are important advances in the treatment of

Analysis of dermatologic events in vemurafenib-treated patients with melanoma. [2013]
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. [2012]
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.

more studies >>

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.

more trials >>

Reports of Suspected Zelboraf (Vemurafenib) Side Effects

Death (241)Fatigue (182)Arthralgia (174)Rash (157)Nausea (122)Decreased Appetite (106)Myalgia (80)Disease Progression (73)Alopecia (72)Diarrhoea (66)more >>


Page last updated: 2014-12-01

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014