Status:
UNKNOWN
AXP107-11 in Combination With Standard Gemcitabine (Gemzar® ) Therapy for Treatment in Patients With Pancreatic Cancer
Lead Sponsor:
Axcentua Pharmaceuticals AB
Conditions:
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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. T...
Detailed 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 an...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at the time of signing the informed consent
- Histologically confirmed adenocarcinoma of the pancreas
- Metastatic or locally advanced, unresectable disease stage III-IV.
- Measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid tumors (RECIST) for target lesions
- Karnofsky Performance Status ≥ 70 at study entry (Appendix 18.4).
- Life expectancy of more than three months
- Negative pregnancy test for female patients
- For fertile women, willingness to perform double-barrier contraception during study and for four weeks after last treatment
- Able and willing to sign the informed consent form
Exclusion
- 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:
- WBC ≤ 3 x 10³/mm³
- ANC ≤ 1.5 x 10³/mm³
- Platelets ≤ 100.000/mm³
- Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
- PT/PTT \> 1.5 x ULN
- Serum creatinine \> 130 μmol/l) or clearance \< 60 ml/min
- AST and/or ALT \> 3 x ULN with the exception of patients with liver metastasis (\> 5 x ULN)
- Alkaline phosphatase \> 3 x ULN
- Total bilirubin \> 3 x ULN
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01182246
Start Date
November 1 2010
End Date
March 1 2016
Last Update
April 23 2014
Active Locations (2)
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1
Dept. of Clinical Science, Intervention and Technology, Div. of surgery, Karolinska University Hospital, Huddinge
Stockholm, Sweden, SE-141 86
2
Dept. of Oncology-Pathology, Karolinska University Hospital, Solna
Stockholm, Sweden, SE-17176