A Phase IB Study of Vismodegib in Patients with Liver Cancer with Varying Degrees of Kidney and Liver Function

Protocol
12-031
Full Title
A Phase IB, Open-Label Pharmacokinetics and Safety Study of the Hedgehog Pathway Inhibitor Vismodegib in Patients with Advanced Solid Malignancies Including Hepatocellular Carcinoma with Varying Degrees of Renal or Hepatic Function
Purpose

Vismodegib is a drug approved for a form of skin cancer called basal cell carcinoma. In this study, MSKCC researchers are evaluating its use in patients with advanced primary liver cancer or hepatocellular carcinoma who have varying degrees of liver and kidney function, including those with abnormal liver and kidney function.

Vismodegib works by inhibiting SMO, a protein which fuels the growth of some cancers, including primary liver cancer and hepatocellular carcinoma. Vismodegib is a capsule that is taken orally (by mouth).

Investigator
Ghassan K. Abou-Alfa, MD
Ghassan K. Abou-Alfa - Physician Profile
Co-Investigators
Leonard Saltz, MD -- Chief,, Gastrointestinal Oncology Service; Head, Colorectal Oncology Section
Leonard Saltz - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic primary liver cancer or hepatocellular carcinoma that is no longer responding to standard treatment or for which no standard therapy exists.
  • Patients may have normal or abnormal liver and kidney function.
  • At least 4 weeks must have passed since completion of prior therapies and entry into the study (2 weeks since any major surgery).
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Disease(s)
Hepatobiliary: Liver Cancer
Locations
ClinicalTrials.gov
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