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NCT04497038 · ClinicalTrials.gov registry record · Phase 1
Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy
A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT04497038: Clinical Trial Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT04497038 is a Phase 1 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04497038, a Phase 1 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
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.
Primary Outcome
MTD/RP2D determined by dose limiting toxicities (DLT) during the first 29 days of therapy. DLTs are outlined in the protocol and assessed per the NCI CTCAE v5.0. The MTD/RP2D will be determined as the dose level with the highest probability of DLT not exceeding 35%.
Interventions
- DRUG Cabozantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-08-06 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 1 |
Why NCT04497038 stopped before completion
NCT04497038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Cabozantinib is the first listed.
NCT04497038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04497038 about?
NCT04497038 is a clinical study titled "Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy". 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.
What is the current status of trial NCT04497038?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2021-08-06. Estimated completion is 2023-05-02.
What interventions are being tested in trial NCT04497038?
The interventions under investigation include: Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT04497038?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04497038's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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