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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01990248

Enrollment

339

Registered

2013-11-21

Start date

2013-03-23

Completion date

2016-07-26

Last updated

2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of non-cutaneous squamous cell carcinoma	2 years
Incidence of cutaneous squamous cell carcinoma	2 years
Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms)	2 years
Incidence of abnormal liver function	2 years

Secondary

Measure	Time frame
Incidence of gastrointestinal polyps	2 years
Incidence of adverse events	2 years
Incidence of a second (or subsequent) primary melanoma	2 years

Countries

Austria, Belgium, Czechia, Germany, Ireland, Italy, Netherlands, Poland, Sweden, United Kingdom

Outcome results