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NCT01015833 · ClinicalTrials.gov registry record · Phase 3
Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
NCT01015833: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01015833 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 356 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01015833, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
Study Summary
This randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with liver cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.
Primary Outcome
Overall survival is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Doxorubicin Hydrochloride
- OTHER Pharmacogenomic Study
- DRUG Sorafenib Tosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2010-02-15 |
| Est. Completion | 2018-08-15 |
| Phase | Phase 3 |
What the finished NCT01015833 record still lists
NCT01015833 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01015833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01015833 about?
NCT01015833 is a clinical study titled "Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer". This randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with liver cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the body. Sorafenib tosyla...
What is the current status of trial NCT01015833?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2010-02-15. Estimated completion is 2018-08-15.
What interventions are being tested in trial NCT01015833?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG), Pharmacogenomic Study (OTHER), Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT01015833?
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 NCT01015833's enrollment target sits among peer trials
356 1024th of 2000 higher than 976 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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