KX-ORAX-012 Oraxol food effect study

• Research type

  Research Study

• Full title

  An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol.

• IRAS ID

  248385

• Contact name

  Louise Rosalyn Carter

• Contact email

  louise.carter@christie.nhs.uk

• Sponsor organisation

  Athenex, Inc

• Eudract number

  2018-000553-42

• Clinicaltrials.gov Identifier

  U1111-1209-1379, Universal Trial Number (UTN)

• Duration of Study in the UK

  2 years, 1 months, 0 days

• Research summary

  This research study is being conducted to determine the effect of food on the exposure to paclitaxel administered orally as Oraxol in patients who have cancer.

  Oraxol is a combination product of 2 separate drugs; oral paclitaxel capsule and HM30181AK-US tablet, a novel P-glycoprotein (P-gp) inhibitor. Oraxol is intended to allow for oral treatment of cancers that would otherwise be treated with intravenous (IV) paclitaxel. To date, Oraxol has been administered in the fasted state and it is unknown if food will increase the exposure to paclitaxel.

  The study is looking to enrol between 6 to 36 patients and will take approximately 24 months, from the first participant in to last participant out. The study will consist of 2 parts. In Part A, the food effect on the treatment will be determined after two single doses of Oraxol, administered as HM30181AK-US 15 mg tablet and paclitaxel 205 mg/m2 capsule, after an overnight fast. The two single doses of Oraxol will be separated by a period of at least 7 days. In one period subjects will consume a standardised meal and in the second period the subjects will remain fasted. The study will look at what the body does to the drug under fasted or fed conditions by taking and examining blood samples.

  In part B, participants will be treated with Oraxol (15mg tablet of HM30181 plus 30mg paclitaxel capsule) after a fast of at least 6h, for 3 consecutive days per week. Participants will continue the treatment until disease progression, toxicity requiring more than 2 dose reductions, withdrawal from treatment, or the subject is no longer benefitting from treatment. In addition to overall safety and tolerability of Oraxol therapy, the part B of the study will also evaluate the activity of Oraxol by measuring tumour responses in these patients.

• REC name

  HSC REC B

• REC reference

  18/NI/0203

• Date of REC Opinion

  18 Dec 2018

• REC opinion

  Further Information Favourable Opinion