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NCT01008566 · ClinicalTrials.gov registry record · Phase 1
Cixutumumab and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01008566: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01008566 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01008566, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of cixutumumab when given together with sorafenib tosylate in treating patients with advanced liver cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with sorafenib tosylate may kill more tumor cells.
Primary Outcome
The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Sorafenib Tosylate
- BIOLOGICAL Cixutumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2009-08 |
| Phase | Phase 1 |
What the finished NCT01008566 record still lists
NCT01008566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01008566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01008566 about?
NCT01008566 is a clinical study titled "Cixutumumab and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer". This phase I trial is studying the side effects and best dose of cixutumumab when given together with sorafenib tosylate in treating patients with advanced liver cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to gro...
What is the current status of trial NCT01008566?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2009-08.
What interventions are being tested in trial NCT01008566?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Sorafenib Tosylate (DRUG), Cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01008566?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01008566's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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