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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)

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.

Vemurafenib (PLX4032): an orally available inhibitor of mutated BRAF for the treatment of metastatic melanoma. [2011]
CONCLUSIONS: Vemurafenib offers a novel, first-line, personalized therapy for

Improved survival with vemurafenib in melanoma with BRAF V600E mutation. [2011]
metastatic melanoma with the BRAF V600E mutation... CONCLUSIONS: Vemurafenib produced improved rates of overall and progression-free

more studies >>

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.

Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with either everolimus or temsirolimus. The safety of these drug combinations will also be studied.

Vemurafenib is designed to block BRAFV600 inside the cancer cells, which is a mutation that is involved in cancer cell growth.

Temsirolimus and everolimus are designed to block the growth of cancer cells, which may cause cancer cells to die.

Trial of Vemurafenib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma [Not yet recruiting]
In this study, the drugs being used are vemurafenib and bevacizumab. Vemurafenib works by blocking a protein called B-RAF. Researchers have found that a large number of melanomas have mutations (changes) in the BRAF gene. The BRAF gene codes for a protein called B-RAF, which is involved in sending signals in cells that can lead to cell growth. Research has determined that mutations in the BRAF gene at the V600 position cause a change in the B-RAF protein that can drive the growth and spread of melanoma cells. Vemurafenib works by preventing these altered B-RAF proteins from working, and thereby may block the growth and spread of cancer cells in patients with melanoma. Information from prior research studies suggests that this drug can shrink melanoma tumors in the majority of patients, delay tumor growth and prolong overall survival relative to standard chemotherapy. As a consequence, vemurafenib received FDA approval in August 2011 for the treatment of patients with B-RAFV600 mutant melanoma.

Bevacizumab is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) directed against vascular endothelial growth factor (VEGF). VEGF is a potent growth factor with a well-defined role in normal and abnormal blood vessel formation. In the cancer setting, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. Its expression by the tumor has been associated with worse outcome in patients with a number of tumor types including melanoma. In laboratory experiments, bevacizumab inhibits the growth of several different types of human cancer cells by blocking the effects of VEGF. Bevacizumab has been approved by the FDA for use in combination with first line chemotherapies for treatment of patients with colorectal, breast and lung cancer; however, bevacizumab has not been approved for use in patients with metastatic melanoma.

The purpose of this research study is to determine the effectiveness of using vemurafenib and bevacizumab together relative to vemurafenib alone. This study will investigate whether using both study drugs lengthens the amount of time before a patient's melanoma worsens, increases the number of people whose melanoma responds to treatment and what side effects are associated with the use of both drugs together rather than separately.

Vemurafenib and Sorafenib in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the combination of ZelborafTM (vemurafenib) with Nexavar® (sorafenib) or Xalkori® (crizotinib) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.

Vemurafenib is designed to block a protein called BRAFV600E inside the cancer cells, which is involved in cancer cell growth.

Sorafenib is designed to block the function of important proteins in and outside of cancer cells. These proteins are involved in cancer cells growth and new blood vessel development.

Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause the cancer cells to die.

Vemurafenib in Children With Recurrent/Refractory BRAFV600E-mutant Gliomas [Not yet 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.

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: 2013-02-10

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