Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.

Condition or disease Intervention/treatment Phase
Metastatic Pancreas Cancer Locally Advanced Pancreatic Cancer Pancreatic Adenocarcinoma Drug: EndoTAG-1 Drug: Gemcitabine Phase 3

Detailed Description:
The objective of the study was to assess the safety and efficacy 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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Drug: EndoTAG-1
twice weekly
Other Name: EndoTAG-1 was first developed by Munich Biotech AG (Germany) under the names LipoPac and MBT-0206 and by Medigene AG under the name of EndoTAG-1.

Drug: Gemcitabine
once weekly
Other Name: Gemcitabine Hydrochloride
Active Comparator: Gemcitabine Monotherapy
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.
 Drug: Gemcitabine
once weekly
Other Name: Gemcitabine Hydrochloride


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival [ 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) ]
    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.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ 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) ]
    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.

  2. Percentage of Subjects With Objective Response [ Time Frame: Up to approximately 33.5 months (assessed continuously during treatment) ]
    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 [ 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. ]
    Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30.

  4. Percentage of Subjects With Disease Control According to RECIST v.1.1 [ Time Frame: Up to approximately 33.5 months (assessed continuously during treatment) ]
    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. Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate [ Time Frame: Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course) ]
    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.


Other Outcome Measures:
  1. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score [ Time Frame: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) ]
    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.

  2. Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score [ Time Frame: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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:

    1. WBC ≤ 3 x 10³/mm³
    2. ANC ≤ 1.5 x 10³/mm³
    3. Platelets ≤ 100.000/mm³
    4. Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
    5. aPTT > 1.5 x ULN
    6. Serum creatinine > 2.0 mg/dl (> 176.8 μmol/l)
    7. AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
    8. Alkaline phosphatase > 2.5 x ULN
    9. Total bilirubin > 2 x ULN
    10. 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 nonmelanoma 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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Show Show 68 study locations
Sponsors and Collaborators
SynCore Biotechnology Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Li-Tzong Chen, M.D., Ph.D. National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C
  Study Documents (Full-Text)

Documents provided by SynCore Biotechnology Co., Ltd.:
Study Protocol  [PDF] January 28, 2021
Statistical Analysis Plan  [PDF] June 7, 2021

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: SynCore Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03126435    
Other Study ID Numbers: CT4006
First Posted: April 24, 2017    Key Record Dates
Results First Posted: March 24, 2023
Last Update Posted: May 6, 2023
Last Verified: May 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SynCore Biotechnology Co., Ltd.:
FOLFIRINOX
5-Fluorouracil
folinic acid
 irinotecan
oxaliplatin
Gemcitabine
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
 Endocrine System Diseases
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators