AXP107-11 in Combination With Standard Gemcitabine (Gemzar ) Therapy for Treatment in Patients With Pancreatic Cancer

  • STATUS
    Recruiting
  • participants needed
    44
  • sponsor
    Axcentua Pharmaceuticals AB
Updated on 8 November 2020
cancer
measurable disease
karnofsky performance status
metastasis
pancreatic adenocarcinoma
axp107-11
tumor cells
gemcitabine

Summary

The purpose of this study is to assess the effect and safety of AXP107-11 alone, and in combination with gemcitabine standard therapy, in patients with advanced or metastatic cancer of the pancreas. The safety, pharmacokinetics and efficacy of AXP107-11 in these patients will also be studied.

Description

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 microenvironment. 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.

Details
Condition Adenocarcinoma
Treatment AXP107-11
Clinical Study IdentifierNCT01182246
SponsorAxcentua Pharmaceuticals AB
Last Modified on8 November 2020

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