Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma

Sponsor
Sanofi
Study ID
NCT00791544
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Liver Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AVE1642 — DRUG
    intravenous infusion
  • sorafenib — DRUG
    oral intake
  • erlotinib — DRUG
    oral intake

Study Details

The primary objective of the study is to select the dose of AVE1642 to be administered in patients with liver carcinoma not eligible for local treatment. The secondary objectives of the study are: * To evaluate the safety profile of AVE1642 as single agent and the safety profile of combinations with other anti-cancer therapies of interest in liver carcinoma , including detection of immunogenicity. * To evaluate pharmacokinetics and pharmacodynamics profiles of AVE1642 as single agent or any PK interactions when given in combination with other anti-cancer therapies. * To assess the preliminary clinical activity in terms of response rate (Complete response + Partial response), duration of responses, stabilisation rate and duration of stabilisation, according to RECIST criteria. * To assess the biological activity at the tumor level.

Key Dates

First listed
Nov 14, 2008
Start date
Nov 30, 2008
Status verified
Aug 2010
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -1
    0.5 mg/kg AVE1642 single agent at cycle 1 with sorafenib at cycle 2
  • Experimental: Dose Level 1
    1 mg/kg AVE1642 single agent at cycle 1 with sorafenib at cycle 2
  • Experimental: Dose Level 2
    3 mg/kg AVE1642 single agent at cycle 1 with sorafenib at cycle 2
  • Experimental: Dose Level 3
    6 mg/kg AVE1642 single agent at cycle 1 with sorafenib at cycle 2
  • Experimental: Dose Level 4
    12 mg/kg AVE1642 single agent at cycle 1 with sorafenib at cycle 2
  • Experimental: Dose Level 5
    18 mg/kg AVE1642 single agent at cycle 1 with sorafenib at cycle 2
  • Experimental: Combination cohort 1
    AVE1642 selected dose in combination with sorafenib
  • Experimental: Combination cohort 2
    AVE1642 selected dose in combination with erlotinib

Primary Outcome Measure

Dose-limiting toxicities (DLT) based on grade = or > 3 hematological or non-hematological toxicity and on fasting hyperglycemia [ Time Frame: Cycle 1 and cycle 2 (6 weeks) ]

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