Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005752

Trial Description

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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

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Trial Acronym

ReLive

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005752
  •   2014/05/08
  •   2012/07/26
  •   no
  •   [---]*
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Secondary IDs

  •   2011-002843-92 
  •   NCT01655693  (ClinicalTrials.gov)
  •   BA2011/03/04  (BioAlliance Pharma SA)
  •   2011-002843-92 
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Health Condition or Problem studied

  •   Carcinoma, Hepatocellular
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
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Interventions/Observational Groups

  •   Drug: Doxorubicin
  •   Drug: Doxorubicin
  •   Drug: Best Supportive Care
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Overall survival(OS) in each group; time frame: at 1 year (expected average); 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.

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Secondary Outcome

- 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; 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.

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Countries of Recruitment

  •   France
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Locations of Recruitment

  • [---]*
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Recruitment

  •   [---]*
  •   2012/06/30
  •   390
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • BioAlliance Pharma SA
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    • Croix-Rousse Hospital - Lyon-France
    • Philippe Merle, MD 
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    •   [---]*
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    • Berangere Vasseur, MD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2014/02/11
* This entry means the parameter is not applicable or has not been set.