MIN-001-1203: 2-OHOA in advanced solid tumours, V1.0

• Research type

  Research Study

• Full title

  A Phase 1/2A Dose Escalation Study of 2-hydroxyoleic acid (2-OHOA; Minerval®) in Adult Patients with Advanced Solid Tumours including Malignant Glioma

• IRAS ID

  118512

• Contact name

  Johann de Bono

• Sponsor organisation

  Lipopharma Therapeutics SL

• Eudract number

  2012-001527-13

• ISRCTN Number

  ISRCTN

• Research summary

  2OHOA is a derivative of oleic acid, a component of olive oil. In laboratory experiments it demonstrated the ability to stop the growth of, as well as kill cancer cells. It does so by causing changes in the levels of fats in cancer cell membranes (the outer lining of cells) which in turn affects the way messages are relayed to the centre of cells leading to growth arrest and cell death. In these experiments, 2OHOAwas able to slow the growth of various types of cancer including the rare and difficult to treat gliomas (brain tumours).This is the first study of 2OHOA in cancer patients. The aims of this study are to:?½ find the highest safest dose of 2OHOA ?? the maximum tolerated dose?½ define the side effects of 2OHOA?½ define how the body handles 2OHOA (pharmacokinetics)?½ define how 2OHOA affects cancer cells (pharmacodynamics)?½ see how effective 2OHOA may beThe study will be performed in two parts:Part 1dose escalation phase of about 30 patients treated at increasing doses of 2OHOAPart 2 ?? dose expansion phase of about 20 patients treated at the highest safe dose.Patients will receive 2OHOA as a liquid orally twice daily every day in 21day cycles. They will attend for overnight stays and day visits for tests to gain the required information on the study drug and monitor any side effects. They will be monitored for any benefit with scans every 2 cycles (starting from the third cycle). Most patients will receive between 1 and 6 cycles of 2OHOA over 3 to 18 weeks and may continue beyond 6 cycles if there is benefit to them and they tolerate the drug.Patients will be recruited from 4 hospitals in the UK and Europe. The study is sponsored by Lipopharma Therapeutics SL.

• REC name

  London - Central Research Ethics Committee

• REC reference

  13/LO/0062

• Date of REC Opinion

  26 Mar 2013

• REC opinion

  Further Information Favourable Opinion