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Clinical Trial Record

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

2018-10-16

2021-07-30

2021-10-08

218

Study Overview

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

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.

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

  • Metastatic Pancreas Cancer
  • Locally Advanced Pancreatic Cancer
  • Pancreatic Adenocarcinoma
  • DRUG: EndoTAG-1
  • DRUG: Gemcitabine
  • CT4006

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2017-04-19  

2022-11-07  

2023-05-05  

2017-04-19  

2023-03-01  

2023-05-06  

2017-04-24  

2023-03-24  

2023-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/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

DRUG: EndoTAG-1

  • twice weekly

DRUG: Gemcitabine

  • once weekly
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

DRUG: Gemcitabine

  • once weekly
Primary Outcome MeasuresMeasure DescriptionTime Frame
Overall SurvivalThe 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.From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment)
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Progression Free Survival (PFS)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.From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment)
Percentage of Subjects With Objective ResponsePercentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.Up to approximately 33.5 months (assessed continuously during treatment)
Duration of ResponseDuration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30.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.1.1Percentage 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.1.1Up to approximately 33.5 months (assessed continuously during treatment)
Serum Carcinoma Antigen 19-9 (CA 19-9) Response RateResponders 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.Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Li-Tzong Chen, M.D., Ph.D., National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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