EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment
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|ClinicalTrials.gov Identifier: NCT03126435|
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : April 29, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreas Cancer Locally Advanced Pancreatic Cancer Pancreatic Adenocarcinoma||Drug: EndoTAG-1 Drug: Gemcitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment|
|Actual Study Start Date :||October 16, 2018|
|Actual Primary Completion Date :||July 30, 2021|
|Actual Study Completion Date :||October 8, 2021|
Experimental: EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly plus gemcitabine 1000mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine 1000mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
- Overall survival [ Time Frame: 1 year ]Overall survival time is defined as time from randomization to death from any cause or last day known to be alive
- Progression Free Survival [ Time Frame: 6 months ]Progression Free Survival time is defined as the time from randomization to either first observation of progressive disease or occurrence of death
- Percentage of subjects with Objective Response [ Time Frame: 1 year ]Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.
- Duration of Response [ Time Frame: 1 year ]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.
- Percentage of subjects with disease control according to RECIST v.1.1 [ Time Frame: 1 year ]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
- Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score [ Time Frame: 1 year ]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.
- Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score [ Time Frame: 1 year ]QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
- Serum Carcinoma Antigen 19-9 (CA 19-9) response rate [ Time Frame: 1 year ]Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥ 18 years
- Written informed consent
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Metastatic or locally advanced disease that is considered unresectable
- Measurable / assessable disease according to RECIST v.1.1
- Documented disease progression on first line FOLFIRINOX
- Negative pregnancy test
- 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).
- ECOG performance status 0 or 1
- Cardiovascular disease, New York Heart Association (NYHA) III or IV
- History of severe supraventricular or ventricular arrhythmia
- History of coagulation or bleeding disorder
- History of acute myocardial infarction within 6 months before randomization
- History of congestive heart failure
- 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)
- aPTT > 1.5 x ULN
- Serum creatinine > 2.0 mg/dl (> 176.8 μmol/l)
- AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
- Alkaline phosphatase > 2.5 x ULN
- Total bilirubin > 2 x ULN
- Albumin < 2.5 g/dL
- Clinically significant ascites
- 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.
- 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
- Documented HIV history
- 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.
- Known hypersensitivity to any component of the EndoTAG-1 and/or gemcitabine formulations
- History of malignancy other than pancreatic cancer < 3 years prior to enrollment, except nonmelanoma skin cancer or carcinoma in situ of the cervix treated locally
- Vulnerable populations (e.g. subjects unable to understand and give voluntary informed consent)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126435
|Principal Investigator:||Li-Tzong Chen, M.D., Ph.D.||National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C|
|Responsible Party:||SynCore Biotechnology Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||April 24, 2017 Key Record Dates|
|Last Update Posted:||April 29, 2022|
|Last Verified:||April 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs