Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma
Overview[ - collapse ][ - ]
Purpose | 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 supportive 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. |
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Condition | Carcinoma, Hepatocellular |
Intervention | Drug: Doxorubicin Drug: Doxorubicin Drug: Best Supportive Care |
Phase | Phase 3 |
Sponsor | BioAlliance Pharma SA |
Responsible Party | BioAlliance Pharma SA |
ClinicalTrials.gov Identifier | NCT01655693 |
First Received | July 26, 2012 |
Last Updated | May 3, 2013 |
Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | July 26, 2012 |
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Last Updated Date | May 3, 2013 |
Start Date | June 2012 |
Estimated Primary Completion Date | December 2014 |
Current Primary Outcome Measures | 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. |
Current Secondary Outcome Measures | 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: Yes]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. |
Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety Doxorubicin Transdrug Study in Patients Suffering From Advanced Hepatocellular Carcinoma |
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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 Supportive Care (BSC) in Patients Suffering From Advanced Hepatocellular Carcinoma (HCC) After Failure or Intolerance to Sorafenib. ReLive Study |
Brief 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 supportive 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. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Carcinoma, Hepatocellular |
Intervention | Drug: Doxorubicin Other Names: Doxorubicin Transdrug (DT) at 20mg/m2Drug: Doxorubicin Other Names: Doxorubicin Transdrug (DT) at 30mg/m2Drug: Best Supportive Care |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 390 |
Estimated Completion Date | December 2014 |
Estimated Primary Completion Date | June 2014 |
Eligibility Criteria | Inclusion Criteria: - Male or non-pregnant, non-breast feeding female; - Aged ≥ 18 years; - Patient with: - advanced HCC (BCLC-C according to BCLC staging classification) having progressed under sorafenib therapy or intolerant to sorafenib, or; - intermediate HCC (BCLC-B) non eligible or non responders to transarterial chemoembolization (TACE), and having progressed under or intolerant to sorafenib therapy - HCC diagnosed according to the AASLD criteria: - Cyto-histology criteria and/or Non-invasive criteria - Without cirrhosis or with a non decompensated cirrhosis (Child-Pugh score from A5 to B7 included); - ECOG Performance Status 0 or 1; - Laboratory tests as follows: - Platelets ≥ 50,000 /mm3 - Neutrophil count ≥ 1000/mm3 - Hemoglobin ≥ 10g/dL - Serum transaminases < 5 ULN (NCI/CTC grades 0, 1, or 2) - Alkaline phosphatases < 5 ULN (NCI/CTC grades 0, 1, or 2) - Serum bilirubin < 35 µM/L (or 2.0 mg/dL); - Signed and dated written informed consent form. Exclusion Criteria: - Cirrhosis with a Child-Pugh score B8-C15; - Untreated chronic hepatitis B; - Patients eligible for curative treatments (transplantation, surgical resection, percutaneous treatment); - Patients eligible for palliative treatments with demonstrated efficacy: TACE, sorafenib (patients who failed to sorafenib treatment or intolerant to sorafenib can be included); - HCC developed on transplanted liver; - HIV infection; - Risk of variceal bleeding; - SaO2 < 95%; - Presence of a significant acute or chronic respiratory disease, pleural effusion; - Presence of recent (< 6 months) or current cardiac failure (class III or IV NYHA classification), recent (< 6 months) acute coronary syndrome, clinically significant ECG abnormalities or recent (less than 6 months) acute vascular diseases (stroke, MI…); - Patients having undergone a 450 mg/m² cumulated dose of doxorubicin; - Patients currently treated with immunosuppressive agents that cannot be stopped; - Patients with unstable ongoing medical/surgical problems; - Patients with a life expectancy of less than 2 months; - Patients who had participated in another clinical trial in the last 30 days; - Women of child-bearing age who are unwilling or unable to use an effective contraception method during the study treatment period and for 2 months after the last administration of study drug, and their male partner(s) refusing to use a condom (if applicable); - Men who are unwilling or unable to use a condom during the study treatment period and for 2 months after the last administration of study drug, and their female partner(s) refusing to use one of the appropriate effective contraception methods (if applicable); - Patients unwilling or unable to comply with protocol requirements and scheduled visits. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Berangere Vasseur, MD +33 (0)1 45 58 76 04 berangere.vasseur@bioalliancepharma.com |
Location Countries | France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01655693 |
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Other Study ID Numbers | BA2011/03/04 |
Has Data Monitoring Committee | Yes |
Information Provided By | BioAlliance Pharma SA |
Study Sponsor | BioAlliance Pharma SA |
Collaborators | Not Provided |
Investigators | Principal Investigator: Philippe Merle, MD Croix-Rousse Hospital - Lyon-France |
Verification Date | May 2013 |
Locations[ + expand ][ + ]
Hospital Amiens | Amiens, France, 80054 Principal Investigator: Eric Nguyen-Khac, MDRecruiting |
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CHU | Angers, France Principal Investigator: Paul CALES, MDNot yet recruiting |
Hospital jean Minjoz | Besançon, France, 25000 Principal Investigator: Vincent Di MartinoRecruiting |
Hospital Saint André | Bordeaux, France, 33075 Principal Investigator: Jean-Frédérique Blanc, MDRecruiting |
CHU | Caen, France Principal Investigator: Isabelle OLLIVIER-HOURMAND, MDNot yet recruiting |
Hospital Estaing | Clermont-Ferrand, France, 63003 Principal Investigator: Armand Abergel, MDRecruiting |
Hospital Henri-Mondor | Creteil, France, 94010 Principal Investigator: Charlotte Costentin, MDNot yet recruiting |
Centre Inter-Communal | Creteil, France Principal Investigator: Isabelle ROSA, MDNot yet recruiting |
CHU | Dijon, France Contact: Patrick HILLON, MDPrincipal Investigator: Patrick HILLON, MD Not yet recruiting |
Hospital Grenoble | La Tronche, France, 38700 Principal Investigator: Jean-Pierre Zarski, MDRecruiting |
CHU Dupuytren | Limoges, France Principal Investigator: Nicole TUBIANA-MATHIEU, MDNot yet recruiting |
Hospital Croix Rousse | Lyon, France, 69317 Principal Investigator: Philippe Merle, MDRecruiting |
Hospital La Conception | Marseille, France, 13005 Principal Investigator: Santandrea Gerolami, MDRecruiting |
Hospital Saint Eloi | Montpellier, France, 34295 Principal Investigator: Georges-Philippe Pageaux, MDRecruiting |
Hospital Brabois | Nancy, France, 54511 Principal Investigator: Jean Pierre Bronowicki, MDRecruiting |
Hospital Hotel Dieu | Nantes, France, 44093 Principal Investigator: Yann Touchefeu, MDRecruiting |
CHU - Hôpital Archet | Nice, France Principal Investigator: Albert TRAN, MDNot yet recruiting |
Hospital La Source | Orleans, France, 45067 Principal Investigator: Barbara Dauvois, MDNot yet recruiting |
Hospital Pitié-Salpetriere | Paris, France, 75013 Principal Investigator: Vlad Ratziu, MDRecruiting |
Hospital Tenon | Paris, France, 75020 Principal Investigator: Jean-Didier Grange, MDNot yet recruiting |
Hôpital Saint-Antoine | Paris, France Principal Investigator: Olivier ROSMORDUC, MDNot yet recruiting |
HEGP | Paris, France Principal Investigator: Julien TAIEB, MDNot yet recruiting |
Hospital Saint Jean | Perpignan, France, 66046 Principal Investigator: Faiza Khemissa-Akouz, MDRecruiting |
Hospital Lyon Sud | Pierre Benite, France, 69495 Principal Investigator: Driffa Moussata, MDNot yet recruiting |
IC LOIRE | Saint-Etienne, France Contact: Jean-Marc PHELIP, MDPrincipal Investigator: Jean-Marc PHELIP, MD Recruiting |
Hospital Civil | Strasbourg, France, 67091 Principal Investigator: Michel Doffoel, MDRecruiting |
Hospital Paul Brousse | Villejuif, France, 94804 Principal Investigator: Gilles Pelletier, MDRecruiting |