Phase I and PK of Debio 0507 in solid tumours or lymphoma

• Research type

  Research Study

• Full title

  Phase I clinical and pharmacokinetic study of Debio 0507 in patients with advanced solid tumours or lymphoma

• Contact name

  Elizabeth Ruth Plummer

• Contact email

  ruth.plummer@ncl.ac.uk

• Sponsor organisation

  DEBIOPHARM S.A.

• Eudract number

  2008-003678-16

• ISRCTN Number

  NA

• Research summary

  This is an early phase, first in man, cancer clinical trial designed to assess the safety and effectiveness of a new experimental anti-cancer drug, Debio 0507. Debio 0507 is a DACH platin, the same class of platin as the registered anti-cancer drug oxaliplatin.

  Debio 0507 has been tested in the laboratory and has shown some promise in treating laboratory animals with cancers, but it is not known how effective it will be in treating cancer in patients.
  
  The main aim of the study is to find the highest dose of Debio 0507 that can be given to patients with advanced solid tumours or lymphoma without causing severe side effects. Two dosing schedules are being examined. One group of patients will be given Debio 0507 once every 3 weeks and another group of patients will be given Debio 0507 once every 2 weeks. As the future development of Debio 0507 is likely to be as part of a combination regimen, or as an alternative to oxaliplatin, it is important to test both administration schedules currently recommended for platin containing regimens.
  
  For each dosing schedule, groups of 3-6 patients will be given Debio 0507 as an intravenous infusion over 2 hours. The dose given to each successive group of patients will be increased gradually until the highest safe dose has been determined. Once the highest safe dose of Debio 0507 has been determined, the number of patients studied at this dose level will be increased to confirm the suitability of the dose, and to look for signs of anti-tumour activity.

  The study aims to find out more about the side effects that may result from this new drug.
  
  The study will also examine the pharmacokinetics of Debio 0507. Pharmacokinetics are blood and urine tests which will provide information about how quickly the body absorbs, breaks down and gets rid of the drug.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  09/H0907/2

• Date of REC Opinion

  11 Feb 2009

• REC opinion

  Further Information Favourable Opinion