PANTHER

• Research type

  Research Study

• Full title

  AZD8931, an inhibitor of EGFR, ERBB2 and ERBB3 signalling, in combination with FOLFIRI: A Phase I/II study to determine the importance of schedule and activity in colorectal cancer

• IRAS ID

  107473

• Contact name

  Daniel Hochhauser

• Sponsor organisation

  University College London

• Eudract number

  2012-002811-25

• Research summary

  The PANTHER trial will be looking at combining AZD8931, a new drug, with standard chemotherapy treatment (FOLFIRI), to see if treating patients with colorectal cancer (CRC) with AZD8931 and FOLFIRI is safe and doesn??t cause too many side effects, and if it is better for treating CRC than FOLFIRI on its own. We also want to see whether how frequently AZD8931 is taken changes the side effects it causes or how effective the treatment is. We will compare two different schedules for taking AZD8931 (??continuous? and ??pulsatile? schedules). The trial is divided into two parts ?? phase I and phase II. The purpose of the phase I trial is to assess how the two schedules of AZD8931 are tolerated when added to FOLFIRI. This is a dose escalation trial which aims to determine the recommended dose for each AZD8931 schedule when combined with FOLFIRI. We'll also take extra blood and biopsies to see if AZD8931 affects how FOLFIRI works or vice versa, and learn more about how the drugs work to shrink cancers. Phase II will be a randomised controlled trial using the recommended doses for the continuous and pulsatile schedules of AZD8931 combined with FOLFIRI and comparing them to FOLFIRI alone. The main aim of phase II is to see whether combining AZD8931 with FOLFIRI is better at shrinking CRC than just giving FOLFIRI by itself. FOLFIRI will be given once every two weeks through a drip into a vein. AZD8931 tablets will be taken by mouth. Scans, blood tests and regular examinations will be performed before and throughout treatment to see if the treatment is working and ensure that is safe to continue. Treatment will last for as long as the patient is benefitting from it, after which they will be followed up for up to three years.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/1822

• Date of REC Opinion

  13 Nov 2012

• REC opinion

  Favourable Opinion