Clinical Trials List
2018-07-01 - 2020-06-30
Phase III
Terminated11
ICD-10C25.0
Malignant neoplasm of head of pancreas
ICD-10C25
Malignant neoplasm of pancreas
ICD-10C25.9
Malignant neoplasm of pancreas, unspecified
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
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Trial Applicant
Chang Bing Show Chwan Memorial Hospital
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Sponsor
SynCore Biotechnology Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chia-Jui Yen Division of General Internal Medicine
- 姜乃榕 Division of General Internal Medicine
- Yan-Shen Shan Division of General Surgery
- Nai-Jung Chiang Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張正雄 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
1 Stop recruiting
Audit
CRO
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Taiwan National PI
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary efficacy endpoint is Overall Survival (OS).
Overall survival time is defined as time from randomization to death from any cause
or last day known to be alive.
Secondary Efficacy Endpoints
The secondary efficacy endpoints are as follows:
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). Questions include on altered bowel habits, pain, dietary changes, disease
and Tx-related symptoms and issues related to the emotional and social wellbeing 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.
7. Serum Carcinoma Antigen 19-9 (CA 19-9) response rate
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).
Inclution Criteria
Potential subjects are required to meet all of the following criteria for enrollment into
the study and subsequent randomization:
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
Exclusion Criteria
Potential subjects meeting any of the following criteria will be excluded from
enrollment and subsequent randomization:
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)
The Estimated Number of Participants
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Taiwan
34 participants
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Global
218 participants
