Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas MedDRA version: 8.1 Level: LLT Classification code 10052747 Term: Adenocarcinoma pancreas
Conditions
Interventions
Product Name: EndoTAG-1
Product Code: EndoTAG-1
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Paclitaxel
CAS Number: 33069-62-4
Current Sponsor code: MDG.09.100
Other desc
Sponsors
MediGene AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Written informed consent - Histologically or cytologically confirmed, pancreatic adenocarcinoma suitable for chemotherapy - Clinical diagnosis of irresectable pancreatic adenocarcinoma ECOG Performance Status 0, 1 or 2 - = 18 years old - Negative pregnancy test (females of childbearing potential) - Willingness to perform double-barrier contraception during study and for 6 months post chemotherapy treatment 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: - Cardiovascular disease, New York Heart Association (NYHA) III or IV - History of severe supraventricular or ventricular arrhythmia - History of coagulation or bleeding disorder (PTT > 1.5 x ULN) - Severe pulmonary obstructive or restrictive disease - Diabetic retinopathy - 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 1000/ mm3 - ANC = 1.5 x 1000/mm3 - Platelets = 100.000 / mm3 - Hb = 9.0 g/dl (= 5.6 mmol/l) - PT/PTT > 1.5 x ULN - Serum creatinine > 2.0 mg/dl (> 176.8 mmol/l) - AST and/or ALT > 5 x ULN - Alkaline phosphatase > 2 x ULN - Total bilirubin > 2 x ULN - Immunotherapy < 6 weeks prior to enrollment - Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment - Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field - Major surgery < 4 weeks prior to enrollment - Pregnant or nursing - Investigational medicinal product < 4 weeks of enrollment - HIV history - Hypersensitivity to any component of the EndoTAG™-1 and/or gemcitabine formulations - History of significant liver pathology (other than metastases) - History of malignancy other than pancreatic cancer < 5 years prior to enrollment, except skin cancer treated locally - Vulnerable populations (e.g. subjects incapable of giving consent personally)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Objectives: · Assessment of the safety of biweekly infusions of EndoTAG™-1 and weekly infusions of gemcitabine via: · Incidence and percentage with patients EndoTAG™-1 and gemcitabine related AE · Laboratory abnormalities (hematology, coagulation parameters, clinical chemistry, urine analysis) · Dose reductions, pausing and/or discontinuations of EndoTAG™-1 and/or gemcitabine Efficacy Objectives: · Assessment of survival (progression free survival, 6-month survival rate, overall survival) · Tumor response evaluation after 14 applications of EndoTAG™-1 and 7 applications of gemcitabine, i.e. 1 week after last treatment and according to follow-up plan · Clinical Benefit Assessment via Quality of Life (QoL) Scale (EORTC-QoL-C30-Questionnaire, PAN-26-module) · Assessment of clinical status via ECOG Scale;Secondary Objective: none ;Primary end point(s): Efficacy Endpoints · Median progression free survival (PFS) · 6-month-survival-rate calculated by the rate of patients alive 6 months after start of treatment · Median overall survival (OS) · Tumor Response (CR / PR / SD / PD) after 14 applications of EndoTAG™-1 and 7 applications of gemcitabine (1 cycle) assessed by the following variables: CT/MRI scans, chest X-ray and CA19-9 level kinetics · Clinical Benefit via Assessment of Quality of Life (QoL): EORTC-QoL-C30-Questionnaire + PAN-26-module · Pain assessment (Visual analogue scale = VAS) · ECOG: Number of patients with improvement/ steady state/ deterioration at week 8 compared to baseline · CA 19-9: Number of subjects with increase/no change/decrease between baseline and end of treatment, number of subjects within the normal range at baseline and at end of treatment Safety endpoints · Adverse Events: Incidence and percentage of patients with treatment emergent AEs · Laboratory Values: Number of clinically significant abnormal laboratory values · Dose variations: Percentage of patients having dose reductions/ pausing or discontinuatio | — |
Countries
Czech Republic, Germany, Hungary, Sweden
Outcome results
None listed