AP26113 in patients with Non-Small Cell Lung Cancer

• Research type

  Research Study

• Full title

  A Randomised Phase 2 Study of AP26113 in Patients with ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated with Crizotinib

• IRAS ID

  141618

• Contact name

  Minal Kara

• Contact email

  minal.kara@parexel.com

• Sponsor organisation

  ARIAD Pharmaceuticals, Inc.

• Eudract number

  2013-002134-21

• Clinicaltrials.gov Identifier

  NCT02094573

• Research summary

  The purpose of this study is to measure AP26113 (study drug) in patients who have a specific type of Non-Small Cell Lung Cancer (NSCLC). Only patients with NSCLC that have cancer cells containing an abnormal form of a protein called ALK will enrol into this study. Patients will be invited to participate in the study because their prior treatment, crizotinib, has failed to control the growth of their cancer.
  Laboratory and animal research studies suggest that AP26113 stops cancer cells from growing by interacting with ALK protein.
  Alternative possible treatments for NSCLC include treatment with chemotherapy drugs that the patient may or may not have yet received participation in another research study or no therapy specific to their cancer and comfort care, also called palliative care. This type of care may help to reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to treat the symptoms.

  It’s expected the study will last approximately 3 years, in which over this time period, patients will take orally a once daily treatment of AP26113 until they discontinue the research study. The length of time participants will take AP26113 will depend on their cancer status and how well they tolerate AP26113.
  This study is sponsored by the pharmaceutical company, ARIAD Pharmaceuticals Inc. and it is anticipated that approximately 218 patients will participate across 100 sites globally.
  This is a randomised, open label study. Participants will be randomised in a 1:1 ratio to receive AP26113 in one of two different dosing regimens.
  Arm A: AP261136 will be administered at a dose of 90mg
  Arm B: AP261136 will be administered at a dose of 90mg for 7 days and then 180 mg continuously.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  14/EM/1139

• Date of REC Opinion

  26 Nov 2014

• REC opinion

  Further Information Favourable Opinion