Study of BYL719-LJM716 combination in patients with oesophageal cancer

• Research type

  Research Study

• Full title

  A phase Ib/II, open-label study of LJM716 in combination with BYL719 compared to taxane or irinotecan in patients with previously treated esophageal squamous cell carcinoma

• IRAS ID

  131040

• Contact name

  W Mansoor

• Contact email

  Was.Mansoor@christie.nhs.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-005624-15

• Research summary

  This is a study looking at a potential new treatment for patients with oesphageal squamous cell cancer.
  This study is divided into 2 parts;
  The Phase Ib part of the study is a dose finding study to find the a safe dose / MTD(maximum tolerated dose) of LJM716 and BYL719 to be used in combination, based on the side effects seen from the combination and also how the body breaks down the drugs.
  The Phase 2 part of the study will look at safe dose / MTD of BYL719 + LJM716 (determined in the Phase 1b) against the standard of care treatments currently available i.e irinotecan, docetaxel, paclitaxel, to see whether there is any benefit in the combination over the standard therapy currently available in terms of anti tumour activity (how well the patients cancer is controlled). Patients will have a 50% chance of receiving the combination of LJM16 or BYL719 or the chemotherapy chosen by their doctor.

  The medicine being tested in this study is LJM716 a new type of drug which keeps the HER3 protein receptor inactivated (indicated to inhibit tumour growth) by binding to it and also inhibiting HER2 receptor binding and activation of the HER3 receptor. BYL716 is a PI3K inhibitor which blocks signalling from the PI3K protein (indicated to inhibit tumour growth) by binding to it. It is thought that the combination of BYL719 and LJM716 will better control a patients cancer than if they were given separately. It is also thought that the combination may control a patients cancer better than standard therapies available.
  At least 97 patients with oesphageal squamous cell carcinoma will join the study (at least 15 patients will participate in the phase 1b part of the study and at least 84 patients in the phase 2).
  This trial is sponsored by the pharmaceutical company named Novartis.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0477

• Date of REC Opinion

  8 Aug 2013

• REC opinion

  Further Information Favourable Opinion