Study on Vismodegib for Patients with Advanced or Metastatic Basal Cell Carcinoma

Sponsor: Genentech, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT01160250

This clinical trial is testing the drug Vismodegib in patients with advanced or metastatic basal cell carcinoma who have no other satisfactory treatment options. The study aims to provide access to this medication and evaluate its effects.

Patient Parameters

Program Overview

This study is offering Vismodegib, a medication for patients with advanced basal cell carcinoma (BCC) that cannot be treated with surgery or has spread to other parts of the body. The trial is open to patients who have no other effective treatment options available.

Eligibility Criteria

Inclusion Criteria

  • For patients with metastatic BCC, confirmation that the cancer has spread to distant parts of the body.
  • For patients with locally advanced BCC, at least one tumor that is 10 mm or larger and confirmation from a surgeon that it cannot be removed or surgery is not suitable.
  • Patients with locally advanced BCC should have received radiation therapy unless it is not appropriate. If radiation was given, the disease must have worsened afterward.
  • Patients with Gorlin syndrome can join if they meet the criteria for advanced or metastatic disease.
  • Patients with measurable or non-measurable disease are eligible.
  • Must have adequate organ function.
  • Women who can become pregnant must agree to use two forms of birth control, including one barrier method, during the study and for 12 months after stopping Vismodegib.
  • Men with female partners who can become pregnant must agree to use a latex condom and advise their partner to use another form of birth control during the study and for 3 months after stopping Vismodegib.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Life expectancy of less than 12 weeks.
  • Receiving other cancer treatments not specified in the study.
  • Must have completed any recent cancer treatment at least 21 days before starting the study.
  • Uncontrolled medical conditions, such as infections needing IV antibiotics.
  • Any other health issues that could interfere with the study or increase the risk of complications.
  • Unwilling to use effective birth control methods.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.