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A Phase 2, Open-Label Study with Orally Administered CVM-1118 and Sorafenib in Subjects with Advanced Hepatocellular Carcinoma (TaiRx)

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03582618

Background Information

The purpose of this study is to test the effectiveness, safety, and tolerability of an investigational drug combination of CVM-1118 and sorafenib in participants with advanced HCC.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Participants must be 18 years of age or older
  • Pathologically or cytologically-confirmed or diagnosed clinically in accordance with American Association for the Study of Liver Diseases (AASLD) criteria18 (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion), advanced-stage hepatocellular carcinoma without prior systemic anti-cancer therapy
  • Additional eligibility in protocol

Ineligibility Information

  • Major surgery (other than diagnostic surgery) or radiation therapy within 28 days of starting study treatment
  • Known HIV-positive
  • Patients with impaired gastrointestinal (GI) diseases that may significantly alter the absorption of oral medications
  • History of clinically significant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure (New York Heart Association classification ≥ 2), unstable angina, poorly controlled arrhythmias, myocardial infarction within 6 months of study entry
  • Additional ineligibility in protocol

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03582618?term=03138512&rank=1