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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 is a Phase 3 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 397 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01655693
The ClinicalTrials.gov registry entry for NCT01655693 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 397 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valerio Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Doxorubicin 20 mg/m2 is the first listed.
NCT01655693 reports 0 study locations.
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.
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