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NCT01655693 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma
A Phase 3 study, sponsored by Valerio Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 397
- Enrollment target
NCT01655693: Completed Phase 3 study, sponsored by Valerio Therapeutics.
NCT01655693 is a Phase 3 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 397 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01655693, a Phase 3 study, has completed, sponsored by Valerio Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 397 participants
- Enrollment target
Study Summary
The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC) after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and with good liver functions are eligible. Only those who can not benefit from treatment for which efficacy is demonstrated are eligible. These patients are usually proposed either best standard of care (BSC) or participation to clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2 or DT at 30 mg/m2 or the BSC.
Primary Outcome
OS is defined as the time from date of randomization to the date of death from any cause.
Interventions
- DRUG Doxorubicin 20 mg/m2
- DRUG Doxorubicin 30 mg/m2
- DRUG Best Standard of Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2012-06 |
| Est. Completion | 2019-05 |
| Phase | Phase 3 |
What the finished NCT01655693 record still lists
NCT01655693 is an interventional study that assigns participants to a tested intervention. The registered 397 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 (49% lower).
The record links to 0 conditions, and to 3 interventions - of which Doxorubicin 20 mg/m2 is the first listed.
NCT01655693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01655693 about?
NCT01655693 is a clinical study titled "Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma". The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC) after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and with good liver functions...
What is the current status of trial NCT01655693?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 397 participants. The study started on 2012-06. Estimated completion is 2019-05.
What interventions are being tested in trial NCT01655693?
The interventions under investigation include: Doxorubicin 20 mg/m2 (DRUG), Doxorubicin 30 mg/m2 (DRUG), Best Standard of Care (DRUG).
Who is sponsoring clinical trial NCT01655693?
This trial is sponsored by Valerio Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01655693's enrollment target sits among peer trials
397 964th of 2000 higher than 1,037 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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