Niiki Phase I/II study, NKP 1339

• Research type

  Research Study

• Full title

  A PHASE I DOSE ESCALATION STUDY OF NKP-1339 ADMINISTERED ON DAYS 1 THROUGH 4 OF EACH 21-DAY CYCLE IN PATIENTS WITH ADVANCED SOLID TUMOURS REFRACTORY TO TREATMENT

• IRAS ID

  30714

• Contact name

  Christopher Twelves

• Sponsor organisation

  NIIKI PHARMA, INC.

• Eudract number

  2009-012156-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  In pre-clinical studies NKP-14 showed activity against a broad range of tumour types, including those which were resistant to the standard anti-cancer agents (e.g., platinums, taxanes, anthracyclines). The mechanism of tumour cell killing is different from the mechanism of action of other anti-cancer drugs and is believed to be the main reason why NKP-1339 may be active against tumours that are resistant to other current anti-cancer agents. Anti-tumour activity was seen at doses that had minimal toxicity and this was somewhat borne out by the early clinical exploratory study with NKP-14. Therefore, in view of the urgent need for new anti-cancer agents and the positive animal and early clinical work to date, a formal Phase I dose-escalation study to include a new schedule, which looks at potentially higher doses, and an examination of the metabolism, absorption and excretion of the action of NKP-1339 is warranted.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/79

• Date of REC Opinion

  10 Aug 2009

• REC opinion

  Further Information Favourable Opinion