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A Clinical Study to Characterize Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma for Utilization of Target Engagement and Pharmacodynamic Biomarkers in Future Phase I Trials


Phase 1
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma

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Trial Information

A Clinical Study to Characterize Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma for Utilization of Target Engagement and Pharmacodynamic Biomarkers in Future Phase I Trials


Inclusion Criteria:



- Diagnosed with HCC.

- Candidate for surgical resection or has no contraindications to MRI procedures.

Exclusion Criteria:

- Prior loco-regional treatment of tumor, unless there is untreated tumor present
representing a distinct untreated nodule.

- Confirmed or suspected diagnosis of fibrolamellar HCC, mixed HCC/cholangiocarcinoma
or metastatic tumor.

- Had a liver transplant.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Expression levels of beta-catenin mRNA from core needle biopsy (CNB) equivalents of resected HCC.

Outcome Time Frame:

Visit 3, approximately 7 days after screening Visit 1.

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

0000-215

NCT ID:

NCT01521780

Start Date:

April 2012

Completion Date:

November 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • MRI
  • pharmacogenomics
  • beta-catenin
  • Carcinoma
  • Carcinoma, Hepatocellular

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