A Phase II Study of CP-751,871 in Patients With Recurrent and/or Metastatic Squamous Head and Neck Carcinoma
CP-751,871 will be administered as an open-label intravenous solution. All patients will be
treated every 3 weeks until disease progression(by RECIST criteria) or unacceptable toxicity
death or discontinuation from the study for any other reason.
Since, head and neck tumors are easily accessible for iterative biopsy, this study will
offer the opportunity to get tumor biopsies before and after CP-751,871. Our study will
allow translational research with biopsies at crucial timing:
(i) at baseline before any treatment, (ii) during the treatment with CP-751,871 (day 1,
second cycle two hours after the injection of CP-751,871).
(iii) for patients with stable disease or partial response, a new biopsy will be performed
at the time of disease progression to try to understand the mechanisms of tumor resistance.
The baseline samples will allow an investigation of molecular profiles that reflect an
inherent inter-patient variability and which will be predictive of response. Although the
number of patients included is low, these data may contribute to understand the mechanisms
of response and non-response to CP-751,871. Understanding the mechanisms of response to
CP-751,871 will help in the rational design of further clinical trials in head and neck
cancer using CP-751,871.
The on-treatment samples will help to dynamically monitor the molecular response to
The study of involved pathways before and after administration of CP-751,871 could be
performed using IHC, DNA sequence analysis and RNA expression profiling. Plasma samples
could be also stored for further analysis.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the efficacy of CP-751,871 alone in patients with head and neck cancer in term of overall response rate and stable disease (RECIST)
Jean-Pascal Machiels, MDPhD
Cliniques Universitaires Saint-Luc-UCL
Belgium: Federal Agency for Medicinal Products and Health Products