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A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Basal Cell Carcinoma

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Trial Information

A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Patients with basal cell carcinoma (BCC) who meet either of the following
definitions:

- Patients who were determined with advanced disease (aBCC) within 90 days prior
to study enrollment, have not been diagnosed with basal cell carcinoma nevus
syndrome (BCCNS) and have not been treated with an investigational or approved
hedgehog pathway inhibitor

- Patients with aBCC who have not been diagnosed with BCCNS and who were
previously treated with vismodegib as part of Genentech study SHH4476g,
SHH4437g, or SHH4811g (EAP)

- Patients with BCCNS who either have aBCC or multiple BCCs of any stage as
defined by protocol (may include patients previously enrolled in Genentech study
SHH4476g, SHH4437g, or SHH4811g (EAP))

Exclusion Criteria:

- Participation in a clinical trial within 90 days prior to study enrollment that has
either involved treatment of aBCC or involved treatment with an investigational or
approved hedgehog pathway inhibitor, except for patients treated with vismodegib as
part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Response rate

Outcome Time Frame:

approximately 5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Institutional Review Board

Study ID:

ML28296

NCT ID:

NCT01604252

Start Date:

June 2012

Completion Date:

October 2020

Related Keywords:

  • Basal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Louisville, Kentucky  40207
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Indianapolis, Indiana  
Charleston, South Carolina  
Tulsa, Oklahoma  
Las Vegas, Nevada  89109