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Completed

NCT Number: NCT01990248

An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)

This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Feldkirch; Onkologie, Feldkirch, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients of the age of 18 years or older
  • Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
  • Vemurafenib treatment must have been initiated at the time of enrollment or no more than one month prior to enrollment
  • Patient (or legally acceptable representative) has personally signed and dated the informed consent document indicating that he or she has been informed of all pertinent aspects of the study, if applicable
  • Patient is willing to provide information on at least one alternate contact person for study staff to contact regarding the patient's whereabouts, should the patient become lost to follow-up during the course of the study

Exclusion criteria

  • Patient was treated with vemurafenib as part of a clinical trial or expanded access program
  • Patient has participated in any studies involving any investigational study drug within one month prior to initiating vemurafenib treatment
  • Patient has any significant history of disease of medical condition (except metastatic melanoma) which in the judgment of the investigator has the potential to impact participation on the study

Treatment and study plan

Primary outcomes

  1. Incidence of non-cutaneous squamous cell carcinoma

    Time frame: 2 years

  2. Incidence of cutaneous squamous cell carcinoma

    Time frame: 2 years

  3. Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms)

    Time frame: 2 years

  4. Incidence of abnormal liver function

    Time frame: 2 years

Secondary outcomes

  1. Incidence of a second (or subsequent) primary melanoma

    Time frame: 2 years

  2. Incidence of gastrointestinal polyps

    Time frame: 2 years

  3. Incidence of adverse events

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2013
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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