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A Study of Vemurafenib in Participants With Metastatic Melanoma
A Study of Vemurafenib in Participants With Metastatic Melanoma

NCT01307397

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Malignant Melanoma

Interventions: Vemurafenib

Countries: Albania, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer \[AJCC\]) metastatic melanoma.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
* Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
* Participants may or may not have received prior systemic therapy for metastatic melanoma
* Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
* Adequate hematologic, renal and liver function

Exclusion Criteria:

* Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
* Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
* Concurrent administration of any anti-cancer therapies other than those administered in the study
* Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
* Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
Locations (280)
  • Tirana, Albania
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • North Sydney, New South Wales, Australia
  • Waratah, New South Wales, Australia
  • Westmead, New South Wales, Australia
  • Wodonga, New South Wales, Australia
  • Greenslopes, Queensland, Australia
  • Townsville, Queensland, Australia
  • Woolloongabba, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Geelong, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Feldkirch, Austria
  • Graz, Austria
  • Innsbruck, Austria
  • Linz, Austria
  • Salzburg, Austria
  • Salzburg, Austria
  • Sankt Pölten, Austria
  • Vienna, Austria
  • Brussels, Belgium
  • Brussels, Belgium
  • Wilrijk, Belgium
  • Banja Luka, Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina
  • Rio de Janeiro, Rio de Janeiro, Brazil
  • + 250 more on CT.gov