Histologically confirmed, unresectable, locally advanced or metastatic pancreatic cancer stage III-IV MedDRA version: 16.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 100000004864 MedDRA version: 16.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Gemzar®
Product Name: Gemzar® (Gemcitabin)
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: GEMCITABINE HYDROCHLORIDE
CAS Number: 122111-03-9
Product Name: AXP107-11
Product
Sponsors
Axcentua Pharmaceuticals AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Age = 18 years at the time of signing the informed consent 2. Histologically confirmed adenocarcinoma of the pancreas 3. Metastatic or locally advanced, unresectable disease stage III-IV. 4. Measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid tumors (RECIST) for target lesions 5. Karnofsky Performance Status = 70 at study entry (Appendix 18.4). 6. Life expectancy of more than three months 7. Negative pregnancy test for female patients 8. For fertile women, willingness to perform double-barrier contraception during study and for four weeks after last treatment 9. Able and willing to sign the informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Previous or ongoing severe supraventricular or ventricular arrhythmia 2. Previous or ongoing coagulation or bleeding disorder (PTT > 1.5 x ULN) 3. HIV infection 4. Known hypersensitivity to any component of the AXP107-11 formulation or gemcitabine 5. Previous or ongoing significant liver pathology (other than metastases) and/or liver function disorders 6. Previous or ongoing significant chronic renal dysfunction 7. Previous or ongoing malignancy other than pancreatic cancer 3 x ULN - Serum creatinine > 130 µmol/l) or clearance 3 x ULN with the exception of patients with liver metastasis (> 5 x ULN) - Alkaline phosphatase > 3 x ULN - Total bilirubin > 3 x ULN 13. Immunotherapy within six weeks prior to enrolment. 14. Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment 15. Any radiotherapy for pancreatic adenocarcinoma before enrolment except for treatment of bone metastases if target lesions are not included in the irradiated field 16. Major surgery within four weeks prior to enrolment 17. Pregnant or nursing woman 18. Participations in other interventional clinical study within four weeks of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives Phase Ib The primary objective is to determine the safety profile and MTD of AXP107-11 alone and when given in combination with gemcitabine standard therapy. Safety will be assessed by occurrence of adverse events, abnormal changes in laboratory parameters, vital signs, ECG and relevant patient withdrawal. Phase IIa The primary objective is to assess the effect of a combination therapy of AXP107-11 and gemcitabine on objective response rate defined as the percentage of patients who showed complete response (CR) or partial response (PR). ;Secondary Objective: Phase Ib To determine the pharmacokinetic (PK) profile of escalating doses of AXP107-11 when given alone and in combination with gemcitabine. Phase IIa To assess the; - safety and tolerability of a combination therapy of AXP107-11 and gemcitabine. - effect of a combination therapy of AXP107-11 and gemcitabine on overall survival (OS). - effect of a combination therapy of AXP107-11 and gemcitabine on overall survival rate. - effect of a combination therapy of AXP107-11 and gemcitabine on time to progression. - effect of a combination therapy of AXP107-11 and gemcitabine on palliation. - effect of a combination therapy of AXP107-11 and gemcitabine on clinical benefit response. - effect of combination therapy of AXP107-11 and gemcitabine on the tumor mass using positron emission tomography. - effect of a combination therapy of AXP107-11 and gemcitabine on symptom distress score. - effect of a combination therapy of AXP107-11 and gemcitabine on quality of life.;Primary end point(s): • Karnofsky Performance Status scale (KPS) • Clinical Benefit Response (CBR) according to a modified Burris scheme • Tumor response (RECIST) • Tumor marker CA19-9 (for confirmation of tumor response) • Exploratory biomarkers • Positron Emission Tomography (PET) /computed tomography (CT) • Quality of life by EORTC QLQ-C30 questionnaire and PAN26 module • Symptom severity assessment using the Edmonton | — |
Countries
Sweden
Outcome results
None listed