AXP107-11; Clinical phase Ib/IIa trials in oncology
|Coordinator||Axcentua Pharmaceuticals AB|
|Funding from Vinnova||SEK 5 000 000|
|Project duration||October 2010 - October 2013|
Purpose and goal
AXP107-11 is a crystal re-engineered form of genistein, a natural occurring isoflavone, with potential as a therapeutic option for the treatment of cancer. Pre-clinical and epidemiological studies corroborate the inverse correlation between genistein intake and cancer. The primary objectives of the AXP107-11 clinical trial was to determine the safety and tolerability of AXP107-11, alone and in combination with gemcitabine in patients with advanced pancreatic cancer, and the secondary objective was to determine the pharmacokinetic profile of escalating doses of AXP107-11.
Results and expected effects
AXP107-11 was safe and well tolerated at all doses given and in combination with gemcitabine and showed dose proportional kinetics. In some patients partial tumour response and increased overall survival was observed, as well as improved quality of life.
Approach and implementation
A prospective, open label, multi-centre, phase Ib/IIa study was conducted at the Karolinska University Hospital. The objectives were to determine maximum tolerated dose and to investigate safety, tolerability and PK of AXP107-11 alone and in combination with gemcitabine and efficacy of a combination therapy of AXP107-11 and gemcitabine as first-line therapy in patients with unresectable, locally advanced or metastatic adenocarcinoma of the pancreas, stage III-IV. The study was conducted at 2 clinics and the out-come of the study corroborated pre-clinical results.