FIH study of AKN-028 in Patients with Acute Myelogenous Leukemia

• Research type

  Research Study

• Full title

  A Phase 1/2, Open-Label, Multi-Center Dose Escalation, Safety and Tolerability Study of AKN-028 in Patients with Acute Myelogenous Leukemia (AML)

• IRAS ID

  92006

• Contact name

  Matthew Smith

• Sponsor organisation

  Akinion Pharmaceuticals AB

• Eudract number

  2011-003285-33

• ISRCTN Number

  not known

• Research summary

  This is a Phase 1/2 study of a novel FLT3 tyrosine kinase inhibitor, AKN-028, in patients with Acute Myelogenous Leukemia (AML) who have relapsed or are ineligible/intolerant to approved chemotherapy. Patients diagnosed with AML with adequate organ function, as defined in eligibility criteria, who have either relapsed after previous induction chemotherapy or are ineligible for initial or further induction chemotherapy will be included. The study will be conducted in Europe and Russia. Part 1 (Phase 1) will evaluate the safety and tolerability of AKN-028 and determine the dose for further evaluation in the Part 2 (Phase 2) proof-of-concept portion of the study. Patients will continue to be enrolled into Part 1 of the study until the maximum tolerated dose (MTD) has been determined. After Part 1 has been completed, patients will be enrolled into Part 2 of the study. An individual patient may not participate in both Part 1 and Part 2. For individual patients, the study consists of a screening period to determine patient eligibility, a treatment period consisting of up to 2 cycles in Part 1 or up to 3 cycles in Part 2, and a post-treatment follow-up period.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/1765

• Date of REC Opinion

  29 Dec 2011

• REC opinion

  Further Information Favourable Opinion