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EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126435
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : March 24, 2023
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
SynCore Biotechnology Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Pancreas Cancer
Locally Advanced Pancreatic Cancer
Pancreatic Adenocarcinoma
Interventions Drug: EndoTAG-1
Drug: Gemcitabine
Enrollment 218
Recruitment Details 218 subjects were enrolled between October 2018 and July 2020.
Pre-assignment Details  
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description

EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

Period Title: Overall Study
Started 108 110
Completed 2 6
Not Completed 106 104
Reason Not Completed
Death             90             84
Lost to Follow-up             4             3
Physician Decision             0             1
Withdrawal by Subject             6             12
e.g. Sponsor Decision, General Deterioration...             6             4
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy Total
Hide Arm/Group Description

EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

Total of all reporting groups
Overall Number of Baseline Participants 108 110 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 110 participants 218 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
69
  63.9%
72
  65.5%
141
  64.7%
>=65 years
39
  36.1%
38
  34.5%
77
  35.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 110 participants 218 participants
60.7  (9.98) 61.7  (9.68) 61.2  (9.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 110 participants 218 participants
Female
38
  35.2%
50
  45.5%
88
  40.4%
Male
70
  64.8%
60
  54.5%
130
  59.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 110 participants 218 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
35
  32.4%
31
  28.2%
66
  30.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.9%
2
   1.8%
4
   1.8%
White
56
  51.9%
59
  53.6%
115
  52.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
15
  13.9%
18
  16.4%
33
  15.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 110 participants 218 participants
South Korea 13 18 31
Hungary 15 17 32
United States 6 8 14
Taiwan 21 13 34
Israel 7 6 13
France 20 21 41
Russia 26 27 53
Extent of Disease at Randomization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 110 participants 218 participants
Metastatic
94
  87.0%
95
  86.4%
189
  86.7%
Locally Advanced
14
  13.0%
15
  13.6%
29
  13.3%
ECOG Performance at Randomization   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 110 participants 218 participants
0
49
  45.4%
48
  43.6%
97
  44.5%
1
59
  54.6%
62
  56.4%
121
  55.5%
[1]
Measure Description:

ECOG 0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction.

ECOG 1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).

1.Primary Outcome
Title Overall Survival
Hide Description The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis.
Time Frame From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description:

EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

Overall Number of Participants Analyzed 108 110
Median (95% Confidence Interval)
Unit of Measure: days
226
(183.0 to 278.0)
209
(158.0 to 248.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EndoTAG-1 and Gemcitabine, Gemcitabine Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6647
Comments [Not Specified]
Method Log Rank
Comments P-Value is from a stratified log-rank test.
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis.
Time Frame From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description:

EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

Overall Number of Participants Analyzed 108 110
Median (95% Confidence Interval)
Unit of Measure: days
113
(79.0 to 168.0)
110
(60.0 to 115.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EndoTAG-1 and Gemcitabine, Gemcitabine Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4345
Comments [Not Specified]
Method Log Rank
Comments P-Value is from a stratified log-rank test.
3.Secondary Outcome
Title Percentage of Subjects With Objective Response
Hide Description Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.
Time Frame Up to approximately 33.5 months (assessed continuously during treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 108 subjects that received EndoTAG-1 and Gemcitabine, 11 subjects (11.46%, 11/96) presented with a complete or partial response. There were 6 subjects (6.82%, 6/88) that received Gemcitabine Monotherapy considered to have an objective response. For 12 subjects in the EndoTAG-1 group and 22 subjects in the Gemcitabine Monotherapy group, objective response assessments were missing.
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description:
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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 1000 mg/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: once weekly

Overall Number of Participants Analyzed 96 88
Measure Type: Count of Participants
Unit of Measure: Participants
11
  11.5%
6
   6.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EndoTAG-1 and Gemcitabine, Gemcitabine Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2632
Comments [Not Specified]
Method Regression, Logistic
Comments P-value is from logistic regression model adjusted for stratification factors among non-missing records
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description:
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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 1000 mg/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: once weekly

Overall Number of Participants Analyzed 11 6
Mean (Standard Deviation)
Unit of Measure: Months
5.8  (2.62) 9.1  (6.97)
5.Secondary Outcome
Title Percentage of Subjects With Disease Control According to RECIST v.1.1
Hide Description 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
Time Frame Up to approximately 33.5 months (assessed continuously during treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
There were 12 subjects in the EndoTAG-1 treated group and 22 subjects in the Gemcitabine Monotherapy group that were not included in analysis due to missing records.
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description:

EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

Overall Number of Participants Analyzed 96 88
Measure Type: Count of Participants
Unit of Measure: Participants
57
  59.4%
43
  48.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EndoTAG-1 and Gemcitabine, Gemcitabine Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1002
Comments [Not Specified]
Method Regression, Logistic
Comments P-value is from logistic regression model adjusted for stratification factors among non-missing records.
6.Secondary Outcome
Title Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate
Hide Description 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). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments.
Time Frame Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description:

EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

Overall Number of Participants Analyzed 108 110
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.9%
2
   1.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EndoTAG-1 and Gemcitabine, Gemcitabine Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9882
Comments [Not Specified]
Method Regression, Logistic
Comments P-value is from logistic regression model adjusted for stratification factors among non-missing records.
7.Other Pre-specified Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Hide Description European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC 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 bowled 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.
Time Frame Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))
Hide Outcome Measure Data
Hide Analysis Population Description
Some missing data (Change from baseline is based on subjects with paired values.)
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description:

EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

Overall Number of Participants Analyzed 108 110
Mean (Standard Deviation)
Unit of Measure: score on a scale
Pancreatic pain Number Analyzed 60 participants 53 participants
1.0  (3.0) 1.7  (3.2)
Digestive Number Analyzed 60 participants 53 participants
0.6  (2.1) 0.9  (1.6)
Altered bowel habit Number Analyzed 60 participants 53 participants
0.5  (1.8) -0.1  (1.5)
Hepatic Number Analyzed 60 participants 53 participants
0.0  (0.9) 0.0  (1.1)
Body image Number Analyzed 58 participants 54 participants
0.6  (1.8) 0.7  (1.9)
Health care satisfaction Number Analyzed 59 participants 54 participants
0.8  (1.6) 0.4  (1.6)
Sexuality Number Analyzed 57 participants 50 participants
-0.1  (2.4) 0.8  (2.5)
8.Other Pre-specified Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Hide Description Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (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.
Time Frame Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))
Hide Outcome Measure Data
Hide Analysis Population Description
Some missing data (Change from baseline is based on subjects with paired values.)
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description:

EndoTAG-1 22 mg/m2 twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

Overall Number of Participants Analyzed 108 110
Mean (Standard Deviation)
Unit of Measure: score on a scale
Global health QoL Number Analyzed 60 participants 54 participants
-1.6  (2.7) -2.0  (2.7)
Functional scales Number Analyzed 60 participants 54 participants
5.4  (8.2) 6.9  (9.0)
Symptom scales Number Analyzed 60 participants 54 participants
2.6  (4.4) 2.6  (4.5)
Side effect scales Number Analyzed 60 participants 54 participants
1.3  (2.6) 1.4  (3.0)
Physical Number Analyzed 60 participants 54 participants
2.0  (3.1) 2.4  (3.4)
Role Number Analyzed 60 participants 54 participants
1.1  (1.7) 1.4  (1.9)
Cognitive Number Analyzed 60 participants 54 participants
0.5  (1.2) 0.6  (1.5)
Emotional Number Analyzed 60 participants 54 participants
1.2  (2.6) 1.6  (3.0)
Social Number Analyzed 59 participants 54 participants
0.6  (1.7) 0.9  (1.6)
Fatigue Number Analyzed 60 participants 54 participants
1.5  (2.2) 1.4  (2.1)
Pain Number Analyzed 60 participants 54 participants
0.7  (1.8) 0.9  (2.0)
Nausea/vomiting Number Analyzed 60 participants 54 participants
0.4  (1.5) 0.2  (1.5)
Dyspnoea Number Analyzed 59 participants 54 participants
0.5  (0.9) 0.6  (0.9)
Appetite loss Number Analyzed 60 participants 53 participants
0.5  (1.1) 0.3  (0.9)
Insomnia Number Analyzed 60 participants 53 participants
0.0  (0.9) 0.2  (1.2)
Constipation/diarrhea Number Analyzed 60 participants 54 participants
0.4  (1.2) 0.4  (1.2)
Time Frame Up to approximately 33.5 months (assessed continuously during treatment)
Adverse Event Reporting Description

All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety population (i.e., subject receiving the treatment after randomization). There were 102 subjects treated with EndoTAG-1 + gemcitabine and 102 subjects treated with gemcitabine monotherapy.

Systematic Assessment: regular laboratory testing Non-Systematic Assessment: self-reporting by participants or their family members, occasional assessment/testing

 
Arm/Group Title EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Hide Arm/Group Description

EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/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.

EndoTAG-1: twice weekly

Gemcitabine: once weekly

Gemcitabine 1000 mg/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: once weekly

All-Cause Mortality
EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   91/108 (84.26%)      85/110 (77.27%)    
Hide Serious Adverse Events
EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/102 (50.98%)      48/102 (47.06%)    
Blood and lymphatic system disorders     
Anaemia  1  4/102 (3.92%)  4 1/102 (0.98%)  1
Febrile neutropenia * 1  1/102 (0.98%)  1 2/102 (1.96%)  2
Neutropenia  1  1/102 (0.98%)  1 0/102 (0.00%)  0
Thrombocytopenia  1  1/102 (0.98%)  1 0/102 (0.00%)  0
Cardiac disorders     
Atrial fibrillation * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Cardiac arrest * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Cardiac failure * 1  1/102 (0.98%)  1 1/102 (0.98%)  1
Cardiopulmonary failure * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Ear and labyrinth disorders     
Deafness * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Gastrointestinal disorders     
Abdominal pain * 1  6/102 (5.88%)  8 5/102 (4.90%)  5
Abdominal pain upper * 1  2/102 (1.96%)  2 1/102 (0.98%)  1
Ascites * 1  2/102 (1.96%)  2 1/102 (0.98%)  1
Colitis erosive * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Diarrhoea * 1  2/102 (1.96%)  2 0/102 (0.00%)  0
Duodenal obstruction * 1  0/102 (0.00%)  0 3/102 (2.94%)  3
Duodenal stenosis * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Erosive duodenitis * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Gastric haemorrhage * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Gastric ulcer haemorrhage * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Ileus * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Intestinal obstruction * 1  2/102 (1.96%)  2 0/102 (0.00%)  0
Mechanical ileus * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Nausea * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Obstruction gastric * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Oesophageal varices haemorrhage * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Pancreatitis acute * 1  2/102 (1.96%)  2 0/102 (0.00%)  0
Small intestinal obstruction * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Subileus * 1  1/102 (0.98%)  1 1/102 (0.98%)  1
Upper gastrointestinal haemorrhage * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Vomiting * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
General disorders     
Asthenia * 1  3/102 (2.94%)  3 1/102 (0.98%)  1
Death * 1  0/102 (0.00%)  0 4/102 (3.92%)  4
General physical health deterioration * 1  2/102 (1.96%)  2 1/102 (0.98%)  1
Generalised oedema * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Influenza like illness * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Pyrexia * 1  7/102 (6.86%)  8 1/102 (0.98%)  1
Hepatobiliary disorders     
Bile duct obstruction * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Bile duct stenosis * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Cholangitis * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Cholestasis * 1  0/102 (0.00%)  0 2/102 (1.96%)  2
Hepatitis toxic * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Jaundice * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Jaundice cholestatic * 1  0/102 (0.00%)  0 3/102 (2.94%)  3
Malignant biliary obstruction * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Infections and infestations     
Atypical pneumonia * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Bacteraemia * 1  1/102 (0.98%)  1 1/102 (0.98%)  1
Biliary tract infection * 1  1/102 (0.98%)  1 1/102 (0.98%)  2
Empyema * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Enterococcal bacteraemia * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Escherichia bacteraemia * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Febrile infection * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Herpes zoster * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Liver abscess * 1  2/102 (1.96%)  2 1/102 (0.98%)  1
Peritonitis * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Peritonitis bacterial * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Pneumocystis jirovecii pneumonia * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Pneumonia * 1  2/102 (1.96%)  2 3/102 (2.94%)  3
Sepsis * 1  2/102 (1.96%)  2 1/102 (0.98%)  1
Septic shock * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Upper respiratory tract infection * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Urinary tract infection * 1  1/102 (0.98%)  1 2/102 (1.96%)  2
Injury, poisoning and procedural complications     
Vascular access complication * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Wrist fracture * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Investigations     
Blood bilirubin increased * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Metabolism and nutrition disorders     
Dehydration * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Diabetes mellitus * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Hypercalcaemia * 1  2/102 (1.96%)  2 0/102 (0.00%)  0
Hypokalaemia * 1  0/102 (0.00%)  0 2/102 (1.96%)  2
Hyponatraemia * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/102 (0.98%)  1 1/102 (0.98%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to bone * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Tumour associated fever * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Nervous system disorders     
Cerebral ischaemia * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Encephalopathy * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Ischaemic stroke * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Somnolence * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Psychiatric disorders     
Confusional state * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Renal and urinary disorders     
Haematuria * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Thrombotic microangiopathy * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Dyspnoea * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Interstitial lung disease * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Pleural effusion * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Pulmonary embolism * 1  2/102 (1.96%)  2 1/102 (0.98%)  1
Respiratory distress * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Vascular disorders     
Deep vein thrombosis * 1  1/102 (0.98%)  1 1/102 (0.98%)  1
Hypertension * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Hypotension * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
Hypovolaemic shock * 1  1/102 (0.98%)  1 0/102 (0.00%)  0
Subclavian vein thrombosis * 1  0/102 (0.00%)  0 1/102 (0.98%)  1
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EndoTAG-1 and Gemcitabine Gemcitabine Monotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   101/102 (99.02%)      100/102 (98.04%)    
Gastrointestinal disorders     
Constipation * 1  20/102 (19.61%)  22 20/102 (19.61%)  24
Abdominal Distension * 1  8/102 (7.84%)  9 7/102 (6.86%)  9
General disorders     
Fatigue * 1  19/102 (18.63%)  35 16/102 (15.69%)  22
Chills * 1  18/102 (17.65%)  24 6/102 (5.88%)  12
Oedema Peripheral * 1  18/102 (17.65%)  24 6/102 (5.88%)  12
Investigations     
Platelet Count Decreased * 1  41/102 (40.20%)  200 42/102 (41.18%)  193
Neutrophil Count Decreased * 1  18/102 (17.65%)  83 21/102 (20.59%)  83
White Blood Cell Count Decreased * 1  18/102 (17.65%)  58 17/102 (16.67%)  71
Alanine Aminotransferase Increased * 1  17/102 (16.67%)  43 17/102 (16.67%)  31
Aspartate Aminotransferase Increased * 1  14/102 (13.73%)  30 17/102 (16.67%)  29
Gamma-Glutamyltransferase Increased * 1  11/102 (10.78%)  19 11/102 (10.78%)  14
Blood Alkaline Phosphatase Increased * 1  15/102 (14.71%)  32 5/102 (4.90%)  9
Weight Decreased * 1  13/102 (12.75%)  19 4/102 (3.92%)  6
Lymphocyte Count Decreased * 1  8/102 (7.84%)  39 7/102 (6.86%)  15
Metabolism and nutrition disorders     
Decreased Appetite * 1  35/102 (34.31%)  42 22/102 (21.57%)  28
Hypoalbuminaemia * 1  8/102 (7.84%)  13 5/102 (4.90%)  9
Nervous system disorders     
Neuropathy Peripheral * 1  7/102 (6.86%)  7 4/102 (3.92%)  5
Psychiatric disorders     
Insomnia * 1  9/102 (8.82%)  10 3/102 (2.94%)  3
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  9/102 (8.82%)  14 2/102 (1.96%)  3
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Albert Lin, Ph.D./Special Assistant to GM
Organization: SynCore Biotechnology Co., Ltd.
Phone: +886-2-2760-3688 ext 2308
EMail: JWLin@syncorebio.com
Layout table for additonal information
Responsible Party: SynCore Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03126435    
Other Study ID Numbers: CT4006
First Submitted: April 19, 2017
First Posted: April 24, 2017
Results First Submitted: November 7, 2022
Results First Posted: March 24, 2023
Last Update Posted: May 6, 2023