A Phase I trial of GSK1070916A in patients with advanced solid tumours

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I trial to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Aurora B inhibitor GSK1070916A in patients with advanced solid tumours.

• IRAS ID

  29050

• Contact name

  Chris J Twelves

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2008-005031-15

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Approximately 40 patients with solid tumours refractory to standard therapy or for which no conventional treatment exists, will receive GSK1070916A. GSK1070916A is currently being developed to prevent cancer growth. It blocks enzymes (Aurora kinases (AK)) involved in cell division and may therefore kill the growing cancer cells. Because GSK1070916A has been designed to target a specific pathway known to be disturbed in cancer cells, it is expected to be less toxic than conventional chemotherapy. The drug is directed at a specific member of the AK family, it is more selective than other Kinase Inhibitors so may have greater activity/less toxicity than these compounds. This study will investigate safety & tolerability and see how the body responds to the drug. The study will be conducted at 2 NHS hospitals and standard safety assessments will be performed throughout the trial. GSK1070916A will be administered intravenously over 1 hour, daily for 5 days, every 21 days (21 day cycle). The dose of GSK1070916A will be increased in a controlled fashion as further patients are treated until such time that the side-effects are deemed unacceptable. Initially single patient groups will receive doses of GSK1070916A and will be expanded when side effects are observed. Patients will receive a total of 6 cycles of GSK1070916A, however if the patient shows benefit from the treatment (no growth in tumour size or a decrease in tumour size) then a patient may continue to receive a further 6 cycles. The maximum tolerated dose will be administered to 15-18 patients to further confirm the dose is safe and tolerable to the patient and to define further how the body responds and handles the drug. Patients in this group will be requested to also consent to have either tumour biopsies taken during the trial or to have additional imaging assessments performed during the trial.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/4

• Date of REC Opinion

  3 Mar 2010

• REC opinion

  Further Information Favourable Opinion