Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 63 of 78 for:    vismodegib

Observational Study of Vismodegib (Erivedge) in Patients Treated in Argentina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02438644
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational, noninterventional study is designed to further characterize the effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is estimated to be approximately 12 months.

Condition or disease
Basal Cell Carcinoma

Layout table for study information
Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Effectiveness and Safety of Vismodegib (Erivedge) in Patients Treated in Argentina
Actual Study Start Date : June 30, 2015
Actual Primary Completion Date : July 26, 2017
Actual Study Completion Date : July 26, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Group/Cohort
Study Population
Patients who are prescribed vismodegib in Argentina, according to standard of care and in line with the current SPC and local labeling, are eligible for observation. Dosing and treatment duration of vismodegib are at the discretion of the physician in accordance with local clinical practice and local labeling. Only patients with laBCC or mBCC will be considered in the effectiveness analysis.



Primary Outcome Measures :
  1. Response rate as assessed by the treating physician [ Time Frame: Approximately 12 months ]

Secondary Outcome Measures :
  1. Duration of treatment [ Time Frame: Approximately 12 months ]
  2. Duration of response as assessed by the treating physician [ Time Frame: Approximately 12 months ]
  3. Incidence of adverse events [ Time Frame: Approximately 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is characterized by patients who are prescribed vismodegib in Argentina, according to standard of care and in line with the current SPC and local labeling. Data collection will be prospective except in the cases when a treating physician contacts the vendor for the first time after the patient has started treatment with vismodegib. In these cases the vendor will retrospectively collect data from the start of treatment. Only patients with laBCC or mBCC will be considered in the effectiveness analysis.
Criteria

Inclusion Criteria:

  • Argetine patients prescribed vismodegib according to standard of care and in line with Summary of Product Characteristics (SPC) and local labeling
  • Diagnosis of laBCC or mBCC for the effectiveness analysis

Exclusion Criteria:

  • None specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438644


Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02438644     History of Changes
Other Study ID Numbers: ML29740
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Basal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell