Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma (ReLive)
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.
Drug: Best Standard of Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicentre, Randomised, Controlled, Open-label Study Comparing the Efficacy and Safety of Slow Repeated IV Infusions of 2 Doses of Doxorubicin Transdrug™ (DT) (20mg/m2 and 30mg/m2) to Those of Best Standard of Care (BSC) in Patients With Advanced Hepatocellular Carcinoma (HCC) After Failure or Intolerance to Sorafenib. ReLive Study.|
- Overall survival(OS) in each group [ Time Frame: At 1 year (expected average) ] [ Designated as safety issue: No ]Survival status will be collected at each visit (at least every 2 weeks) during the study treatment period and then every 3 months until death for an expected average of 1 year.
- Incidence and severity of all Treatment Emergent Adverse Events according to NCI-CTC v4.0 scale in each groups [ Time Frame: Until 2 months after last treatment intake ] [ Designated as safety issue: No ]Adverse events will be collected at each visit (at least every 2 weeks) during the study treatment period, and then 2 months after the last treatment intake for an expected average of 6 months.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: Doxorubicin Transdrug (DT) at 20mg/m2
DT will be infused over 6 hours through the intravenous (IV) route at dose of 20 mg/m2 on Day 1 and will be repeated every 4 weeks until disease progression or unacceptable toxicity
Other Name: Doxorubicin Transdrug (DT) at 20mg/m2
Experimental: Doxorubicin Transdrug (DT) at 30 mg/m2
DT will be infused over 6 hours through the IV route at dose of 30 mg/m2 on Day 1 and will be repeated every 4 weeks until disease progression or unacceptable toxicity
Other Name: Doxorubicin Transdrug (DT) at 30mg/m2
Active Comparator: Best Standard of Care
Patients randomized in the control group will receive treatment according to the investigator's choice, until disease progression or unacceptable toxicity
|Drug: Best Standard of Care|
Doxorubicin-Transdrug™ (DT) is a nanoparticle formulation of doxorubicin.In in vitro and in vivo models, DT was shown to overcome the multidrug resistance (MDR) and to be more effective than doxorubicin on both sensitive and resistant tumour models and in particular in the X/myc bi-transgenic MDR murine model of HCC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655693
|Contact: Berangere Vasseur, MD||+33 (0)1 45 58 76 firstname.lastname@example.org|
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|Principal Investigator:||Philippe Merle, MD||Croix-Rousse Hospital - Lyon-France|