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Dose-finding, Safety, Pharmacokinetic and Pharmacodynamic Study of AVE1642, an Anti-Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, Administered as Single Agent and in Combination With Other Anti Cancer Therapies (Sorafenib or Erlotinib) in Patients With Advanced Liver Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Carcinoma

Thank you

Trial Information

Dose-finding, Safety, Pharmacokinetic and Pharmacodynamic Study of AVE1642, an Anti-Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, Administered as Single Agent and in Combination With Other Anti Cancer Therapies (Sorafenib or Erlotinib) in Patients With Advanced Liver Carcinoma


AVE1642 will be administered as an IV infusion on day 1 and then every 3 weeks for at least
2 infusions for evaluability requirements. Curative and / or prophylactic management of
allergic reactions during infusion will be implemented when needed. The duration of the
study for one patient will include a period for inclusion of up to 2 weeks, at least 2
cycles of treatment in dose escalation step (one cycle of AVE1642 alone and at least one
cycle of AVE1642 in combination) and at least one cycle of the combination in the extension
cohort, followed, when possible, by a minimum of 30-day follow-up after the last drug
administration, in order to detect any potential immunogenicity. In the second step, the
patients will continue treatment until disease progression, unacceptable toxicity or
willingness to stop.

The expected enrolment period is 15 months with at least 30 day follow-up after the last
patient treated.


Inclusion Criteria:



- Patients not eligible for surgical resection, liver transplantation, local ablation
techniques or chemoembolisation and with histologically proven liver carcinoma
whenever possible or combination of radiologically documented hypervascular liver
tumour and α foeto protein level ≥ 400 ng/ml

- Signed and dated approved patient informed consent form prior to enrollment into the
study

Exclusion Criteria:

- ECOG performance status > 2

- Inadequate organ function:

- Neutrophils (ANC) < 1,500/mm3

- Hemoglobin < 10g/dl

- Platelets < 100,000/mm3

- Total bilirubin > 1.5 x ULN

- ASAT, ALAT > 3 x ULN

- Creatininemia > 1.5 x ULN (or ≥ 2.0 mg/dl)

- INR > 1.6

- Liver cirrhosis Child Pugh B or C (score > 6)

- HbA1C > 8%

- No measurable or evaluable tumoral lesion

- Patients not eligible for sorafenib therapy and for whom this therapy cannot be
postponed by 3 weeks (during AVE1642 single treatment period) in dose escalation part

- Prior exposure to an anti-IGF-1R class compound

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicities (DLT) based on grade = or > 3 hematological or non-hematological toxicity and on fasting hyperglycemia

Outcome Time Frame:

Cycle 1 and cycle 2 (6 weeks)

Safety Issue:

Yes

Principal Investigator

Olivier Rosmorduc, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital St Antoine, 184 rue du Faubourg St Antoine, 75012 Paris - France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TED10630

NCT ID:

NCT00791544

Start Date:

November 2008

Completion Date:

November 2009

Related Keywords:

  • Liver Carcinoma
  • monoclonal antibody, anti IGF1R
  • Carcinoma
  • Carcinoma, Hepatocellular

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