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Zelboraf (Vemurafenib) - 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 >>


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

Combination of vemurafenib and cobimetinib in patients with advanced BRAF(V600)-mutated melanoma: a phase 1b study. [2014]
MEK inhibition with cobimetinib in patients with advanced BRAF-mutated melanoma... INTERPRETATION: The combination of vemurafenib and cobimetinib was safe and

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

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Clinical Trials Related to Zelboraf (Vemurafenib)

Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer [Recruiting]
The goal of this clinical research study is to learn about how vemurafenib may affect certain biomarkers in patients with PTC. Biomarkers are in the blood/tissue and may be related to your reaction to the study drug. The safety of this drug will also be studied. Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and cancer growth. By blocking this mutation, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing.

The Safety and Efficacy Study of Vemurafenib (CT) Compared With Vemurafenib (Zelbolaf�) in Advanced Patients Harboring the V600 BRAF Mutation [Active, not recruiting]
The safety and efficacy study of Vemurafenib (CT) compared with Vemurafenib (Zelbolaf®) Advanced patients carrying the V600E BRAF mutation.

Vemurafenib in Children With Recurrent/Refractory BRAFV600E-mutant Gliomas [Recruiting]
This is a multicenter, safety and pharmacokinetic trial to determine the MTD and/or select a recommended phase 2 dose (RP2D) of vemurafenib in children with recurrent or refractory gliomas containing the BRAFV600E mutation.

Study of PX-866 and Vemurafenib in Patients With Advanced Melanoma [Terminated]
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.

Study of Vemurafenib, Carboplatin, and Paclitaxel [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with carboplatin and paclitaxel patients with advanced cancer. The safety of the study drug combination will also be studied. Vemurafenib is designed to block a protein (called mutated BRAF) that is only found in moles (spots) of the skin and certain types of cancer cells. This drug may slow the growth of or kill these cells. Carboplatin is designed to slow the growth of cancer cells by stopping them from making new DNA (the genetic material of cells). Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing into new cells.

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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: 2015-08-10

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