Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Michigan Rogel Cancer Center
- Study ID
- NCT04497038
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
- Advanced Adult Hepatocellular Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cabozantinib — DRUGPatients will receive therapy with cabozantinib. Dosage in the trial will start at 40 mg PO daily. Each patient will be assessed for the development of toxicity according to the NCI Common Terminology Criteria for Adverse Events, version 5.0. Dose adjustments may be made per the Time-To-Event modification of the Continual Reassessment Method (TITE-CRM). The maximum dosage will be 60 mg PO daily and the minimum will be 20 mg PO daily.
Study Details
The aim of this study is to determine the safety and efficacy of cabozantinib in the management of unresectable or metastatic hepatocellular carcinoma (HCC) with underlying Child-Pugh class B cirrhosis.
Key Dates
- Start date
- Aug 6, 2021
- Status verified
- Jul 2024
- Primary completion
- May 2, 2023
- Completion
- May 2, 2023
Study Design
- Enrollment
- 3 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CabozantinibCabozantinib 20-60 mg by mouth once daily.
Primary Outcome Measure
Number of DLT Events to Occur [ Time Frame: Up to 29 days after initiating treatment ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | - |
| University of Chicago | Chicago | Illinois | 60637 | - |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | - |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | - |