BP22909-RO5323441 Dose Finding Study

• Research type

  Research Study

• Full title

  Open-label, exploratory, pharmacodynamic (PD)dose-finding study of intravenous RO5323441 in patients with metastatic treatment-refractory colorectal and ovarian cancer.

• IRAS ID

  12597

• Contact name

  Gordon Jayson

• Sponsor organisation

  F Hoffman-La Roche Ltd Basel

• Eudract number

  2009-016014-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  RO5323441 is a humanized monoclonal antibody (a type of blood protein produced artificially). RO5323441 is directed against placental growth factor (PlGF). PlGF plays an important role in the formation of tumour blood vessels and tumour growth. RO5323441 has been shown to reduce tumour growth in laboratory animals. RO5323441 has previously been used in healthy volunteers and patients with cancer and shown to be well tolerated. This study is a multicenter, open label, exploratory dose-finding study in patients with metastatic colorectal and ovarian cancer refractory to standard therapy. The main purpose of the study is to determine the relationship between the concentration of RO5323441 in the blood and potential changes in tumour blood vessels using an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). The study will also look at the pharmacokinetics (the way that a drug is taken up and metabolised by the body) and the pharmacodynamics (the effect of a drug on the body including the disease/tumour) of RO5323441. In addition, the antitumour effect and the safety and tolerability of RO5323441 will be evaluated. RO5323441 will be administered once every two weeks or once every week as an intravenous (i.v.) infusion. The study is designed as an exploratory study. The aim is to identify the optimum dose for phase II studies, using an adaptive design based on data that arise from previously studied patients. Study data will be reviewed by Study Investigators and the company team on an ongoing basis to determine how the next group of patients will be dosed and assessed. This clinical research study is being sponsored by Roche Products Ltd and will be conducted at The Christie Hospital, Manchester as well as at clinical sites in Spain and Belgium. Approximately 50 patients in total are expected to participate in the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/20

• Date of REC Opinion

  16 Apr 2010

• REC opinion

  Further Information Favourable Opinion