Biomarker BO21129 ("Mark")

• Research type

  Research Study

• Full title

  A phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients with Advanced Pancreatic Carcinoma

• Sponsor organisation

  F. Hoffmann-La Roche Ltd.

• Eudract number

  2007-003738-40

• ISRCTN Number

  N/A

• Research summary

  The purpose of this study is to investigate whether it is possible to identify certain disease markers which can be used in the future to predict benefit from treatment with erlotinib (Tarceva©).Currently the treatment options in the second line setting for patients with pancreatic cancer are limited; there are no standard treatments available to NHS patients in the UK. Erlotinib is an investigational drug being studied by Roche for treating pancreatic cancer after a first treatment with chemotherapy has failed (in the 2nd line setting). The drug is already approved for the first line treatment of pancreatic cancer in combination with gemcitabine and as single agent in second line treatment of Non-Small Cell Lung Cancer (NSCLC).Patients will come to the clinic every 3 weeks, where they will be examined and different blood samples will be taken. Every 6 weeks the disease will be assessed via CT or MRI scan, depending on which method was used the first time. In addition blood and urine will be taken for routine assessments. When a patient stops treatment with erlotinib there will be a final full examination performed. After that patients will be contacted every 3 months by the study personnel to inquire about well-being.The estimated total duration of the time patients may receive study drug is approximately 6 months, however patients will be treated with study medication as long as they benefit from the treatment.200 patients (100 per treatment arm: placebo/erlotinib) will be recruited over a planned period of 18 months. It is expected that there will be approximately 20 patients in UK.Patients will be identified from departments where they are already registered or may be referred from another department or hospital. Patients' medical history will be reviewed by the Principal Investigator'sub-investigator or Research Nurse to confirm eligibility for study participation.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  08/H0405/56

• Date of REC Opinion

  15 Jan 2009

• REC opinion

  Further Information Favourable Opinion