Unresectable Locally Advanced/ Metastatic Adenocarcinoma of the Pancreas MedDRA version: 20.0 Level: PT Classification code 10001141 Term: Adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Paclitaxel in cationic liposomes
Product Code: EndoTAG-1
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number:
Sponsors
SynCore Biotechnology Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Age = 18 years 2-Written informed consent 3-Histologically or cytologically confirmed adenocarcinoma of the pancreas 4-Metastatic or locally advanced disease that is considered unresectable 5-Measurable / assessable disease according to RECIST v.1.1 6-Documented disease progression on first line FOLFIRINOX 7-Negative pregnancy test 8-Both male and female patients and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential during the course of the study and for 90 days after last treatment (excluding women who are not of childbearing potential and men who have been sterilized). 9-ECOG performance status 0 or 1 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: 1-Cardiovascular disease, New York Heart Association (NYHA) III or IV 2-History of severe supraventricular or ventricular arrhythmia 3-History of coagulation or bleeding disorder 4-History of acute myocardial infarction within 6 months before randomization 5-History of congestive heart failure 6-Acute or chronic inflammation (autoimmune or infectious) 7-Significant active/unstable non-malignant disease likely to interfere with study assessments 8-Laboratory tests (hematology, chemistry) outside specified limits: a-WBC = 3 x 10³/mm³ b-ANC = 1.5 x 10³/mm³ c-Platelets = 100,000/mm³ d-Hb = 9.0 g/dl (= 5.6 mmol/l) e-aPTT > 1.5 x ULN f-Serum creatinine > 2.0 mg/dl (> 176.8 µmol/l) g-AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN h-Alkaline phosphatase > 2.5 x ULN i-Total bilirubin > 2 x ULN j-Albumin < 2.5 g/dL 9-Clinically significant ascites 10-Any anti-tumor treatment (except FOLFIRINOX as the first-line therapy) for pancreatic adenocarcinoma before enrollment. Note: Patients who have undergone surgical interventions for pancreatic adenocarcinoma will be eligible. 11-Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field 12-Major surgery < 4 weeks prior to enrollment 13-Pregnant or nursing 14-Investigational medicinal product < 4 weeks of enrollment 15-Documented HIV history 16-Active hepatitis B infection requiring acute therapy Note: Subjects infected by the hepatitis B virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria. 17-Known hypersensitivity to any component of the EndoTAG-1 and/or gemcitabine formulations 18-History of malignancy other than pancreatic cancer < 3 years prior to enrollment, except non-melanoma skin cancer or carcinoma in situ of the cervix treated locally 19-Vulnerable populations (e.g. subjects unable to understand and give voluntary informed consent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Overall survival (OS) Overall survival time is defined as time from randomization to death from any cause or last day known to be alive.;Timepoint(s) of evaluation of this end point: Overall survival (OS);Main Objective: The objective of the study is to assess the safety, efficacy and quality of life of a combination therapy of EndoTAG-1 plus gemcitabine vs. gemcitabine monotherapy in patients with locally advanced and/or metastatic adenocarcinoma of the pancreas eligible for second-line therapy after failing first-line therapy with FOLFIRINOX. ;Secondary Objective: To assess the safety of twice weekly infusions of EndoTAG-1 with weekly infusions of gemcitabine versus gemcitabine monotherapy according to: -Incidence and percentage of subjects with treatment-emergent adverse events (TEAEs) -Laboratory abnormalities (hematology, coagulation parameters, clinical chemistry) -Dose reductions, pausing, and/or discontinuation of EndoTAG-1 and/or gemcitabine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Progression Free Survival (PFS) Progression Free Survival time is defined as the time from randomization to either first observation of progressive disease or occurrence of death. 2-Percentage of subjects with Objective Response (OR) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1)* Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1. 3-Duration of Response (DR)* Duration of Response is defined as the time from the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause. 4-Percentage of subjects with disease control according to RECIST v.1.1* Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1 5-Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score. 6-Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Quest | — |
Countries
France, Hungary, Israel, Korea, Republic of, Russian Federation, Taiwan, United States
Contacts
Public ContactDep. of SB05 PC Clinical Operations
SynCore Biotechnology Co., Ltd.
Outcome results
None listed