Ceritinib food effect study in ALK positive NSCLC patients

• Research type

  Research Study

• Full title

  A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)

• IRAS ID

  182060

• Contact name

  Alastair Greystoke

• Contact email

  Alastair.Greystoke@newcastle.ac.uk

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2014-004001-32

• Duration of Study in the UK

  1 years, 6 months, 15 days

• Research summary

  In approximately 2- 8% of patients with advanced non-small cell lung cancer (NSCLC), there is a change to a gene called ALK (short for anaplastic lymphoma kinase) within the tumour. This change leads to an abnormal protein (ALK protein) that sends signals to cancer cells telling them to multiply and grow. The drug, Ceritinib (LDK378) is in a class of medications called ALK inhibitors. It works by blocking the abnormal ALK protein in ALK positive cancers. This helps to slow or stop the spread of cancer cells which ultimately stops or slows the growth and the spread of the tumour (known as anti- tumoural activity).

  This anti-tumoural activity of Ceritinib in patients has been demonstrated in previous studies. It has been approved in Europe and the USA for patients with ALK positive NSCLC who have previously been treated with chemotherapy and another ALK inhibitor called Crizotinib.

  Currently, Ceritinib is administered at 750mg daily on an empty stomach. This study will examine the effects of the drug when taken with food. It will also further investigate the safety and anti-tumoural of Ceritinib in this patient population.

  Data from previous studies shows that food increases the levels of Ceritinib in the blood (also known as systemic exposure). This could mean that if Ceritinib is taken with food, patients would require fewer capsules, would require less planning to take their tablets on time and could help to minimize gastro- intestinal side effects such as nausea.

  Around 300 patients will be invited to take part in the study from many different countries including the UK. Only patients who have tested ALK positive and passed the screening assessments will be eligible for treatment. During the treatment period, patients will be asked to take Ceritinib once daily by mouth and attend hospital more frequently than normal for study assessments. Patients will continue to receive study treatment as long as they give permission, the cancer is not growing and they are tolerating the drug without unacceptable side-effects.
  
  This trial is sponsored by the pharmaceutical company Novartis

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  15/YH/0388

• Date of REC Opinion

  15 Sep 2015

• REC opinion

  Further Information Favourable Opinion