Safety, Pharmacokinetics and Efficacy of AXP107-11 in Combination With Standard Gemcitabine (Gemzar®) Treatment in Patients With Locally Advanced or Metastatic, Unresectable, Adenocarcinoma of the Pancreas, Stage III-IV: A Prospective, Open Label, Multi-centre, Sequential Phase Ib/IIa Study
The annual incidence rate of pancreatic cancer is almost identical to the mortality rate.
Despite a low incidence rate, pancreatic cancer is the fourth leading cause of cancer
mortality in both men and women. Today is the only potentially curative option of these
patients complete surgical resection. However, a majority of the patients (up to 80%) are
not eligible for surgery for different reasons.
Today is gemcitabine the accepted first-line treatment for these patients. Recent advances
in the management of pancreatic cancer suggest that gemcitabine may be improved by combining
it with other anticancer drugs.
One attractive therapeutic option is genistein. Genistein appears to sensitize tumors to
chemotherapy both by targeting the tumor cells and also by targeting components of the tumor
However, the limited bioavailability of genistein in its known crystalline form has led to
difficulties in attaining adequate plasma concentration, resulting in limited application
and dissemination in the clinical setting. To overcome this limitation, a novel crystalline
form of genistein with improved pharmaceutical properties is being used. AXP107-11, a
crystalline salt of genistein has improved physiochemical properties (solubility,
dissolution rate, bioavailability) as compared to the known crystalline form of genistein.
In this study, AXP107-11, will be investigated alone and in combination with gemcitabine in
patients with pancreatic cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the safety profile and the maximum tolerated dose (MTD) of AXP107-11 alone and when given in combination with gemcitabine standard therapy.
Safety (AEs, dose limiting toxicity, laboratory tests, vital signs, weight and ECG). MTD is defined at day 8.
up to 6 months
Mattias Löhr, MD,PhD, Prof.
Sweden: Medical Products Agency