NCT04522908

Dose Escalation Study of Cabozantinib for Advanced HCC Patients With Preserved Liver Function

A Phase II Study Evaluating Reduced Starting Dose and Dose Escalation of Cabozantinib as Second-line Therapy for Advanced HCC in Patients With Preserved Liver Function

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label, single arm, multicenter phase II trial assessing the tolerability of a reduced starting dose of 40 mg cabozantinib for 4 weeks and subsequent dose escalation to 60 mg cabozantinib until disease progression or intolerable toxicities.

Detailed description

The primary objective is to assess the tolerability of a reduced starting dose of 40 mg cabozantinib once-daily for 4 weeks and subsequent dose escalation to 60 mg cabozantinib once-daily to be maintained until disease progression or intolerable toxicities. Using the same study treatment discontinuation criteria as in the pivotal CELESTIAL trial will allow for comparison of treatment discontinuation rates due to treatment related adverse events (TRAEs) defined as unresolved intolerable Grade 2 TRAEs or any unresolved Grade 3 TRAEs (see Section 6). Patients eligible for this trial are HCC patients with preserved liver function previously treated with any first line therapy. Secondary objectives comprise the assessment of overall survival (OS), progression free survival (PFS) at 10 weeks, objective response rate (ORR), time on treatment, treatment exposure (dose intensity/dose reductions), toxicity, and quality of life (QLQ-C30). In addition, tissue samples (optional) will be analyzed for molecular parameters and immune cell composition to identify biomarkers potentially associated with clinical efficacy (OS, PFS and ORR). This is an open label, single-arm, multicenter phase II trial. 40 patients suffering from advanced stage hepatocellular carcinoma (HCC) with preserved liver function in second line treatment, after any first line therapy, will be enrolled in this trial. Patients will be recruited from up to 10 sites and patients withdrawn from the trial will not be replaced.

Conditions

• Hepatocellular Carcinoma (HCC)
• Second Line Treatment

Interventions

Type	Name	Description
DRUG	Cabozantinib Oral Tablet	Cabozantinib starting dose of 40 mg, oral, once daily for 4 weeks followed by Cabozantinib escalated dose of 60 mg, oral, once daily from week 5 onwards

Timeline

• Start date: 2020-10-12
• Primary completion: 2024-10-04
• Completion: 2024-10-04
• First posted: 2020-08-21
• Last updated: 2025-01-30

Locations

10 sites across 1 country: Germany