20060447 Phase 1b/2 study with P'mab,AMG 102,AMG 479 colorectal cancer

• Research type

  Research Study

• Full title

  A Randomised, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorectal Cancer

• IRAS ID

  5853

• Contact name

  John Bridgewater

• Sponsor organisation

  University College London

• Eudract number

  2008-001751-21

• ISRCTN Number

  N/A

• Research summary

  The study aims to initially (part 1) identify a tolerable dose of AMG 102 in combination with panitumumab in subjects with wild-type KRAS metastatic colorectal cancer (cancer that has spread to other parts of the body). Part 2 of the study aims to determine if panitumumab when given in combination with AMG 102 (panitumumab and AMG 102) or AMG 479 (panitumumab and AMG 479) is more effective than panitumumab alone in subjects with wild-type KRAS metastatic colorectal cancer.Those patients whose disease progresses whilst receiving Panitumumab alone in Part 2, and who meet the inclusion criteria will get the chance of receiving either AMG 102 or AMG 479 in Part 3. Part 3 will however be double blinded so patients won??t know what treatment arm they have been assigned to.Patients enrolled to the study will undergo a number of procedures, including: general assessments (e.g. vital signs, physical examination, height, weight, ECOG performance status, electrocardiogram), blood sample tests, radiological assessments (e.g. CT scan or MRI) and investigational product administration.Blood samples will be taken throughout the study to test how the body processes the study drug combinations. One of the goals of this study is to identify biomarkers (substances that may be used to measure the effects or progress of disease), therefore some of the blood collected and a sample of tumour may be used for this purpose.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/56

• Date of REC Opinion

  30 Mar 2009

• REC opinion

  Further Information Favourable Opinion