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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.
Full 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.
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Inclusion criteria
Exclusion criteria
Previous or ongoing severe supraventricular or ventricular arrhythmia
Previous or ongoing coagulation or bleeding disorder (PTT > 1.5 x ULN)
HIV infection
Known hypersensitivity to any component of the AXP107-11 formulation or gemcitabine
Previous or ongoing significant liver pathology (other than metastases) and/or liver function disorders
Previous or ongoing significant chronic renal dysfunction
Previous or ongoing malignancy other than pancreatic cancer < five years prior to enrolment, except basal cell carcinoma treated locally
Cardiovascular disease, New York Heart Association (NYHA) classification III or IV16
Severe pulmonary obstructive or restrictive disease
Acute or chronic inflammation (autoimmune or infectious)
Significant active/unstable non-malignant disease likely to interfere with study assessments
Laboratory tests (hematology, chemistry) outside specified limits:
Immunotherapy within six weeks prior to enrolment.
Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment
Any radiotherapy for pancreatic adenocarcinoma before enrolment except for treatment of bone metastases if target lesions are not included in the irradiated field
Major surgery within four weeks prior to enrolment
Pregnant or nursing woman
Participations in other interventional clinical study within four weeks of enrolment
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44 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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