AzTrials
AzTrials

Metastatic Pancreas CancerPhase 3NCT03126435

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

A Phase 3 study testing EndoTAG-1 and Gemcitabine in people with Metastatic Pancreas Cancer and Locally Advanced Pancreatic Cancer, run by SynCore Biotechnology Co., Ltd. at 68 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EndoTAG-1 and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
68 sitesin 7 countries
Study dates
16 Oct 2018to 8 Oct 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)
Show all 29Show fewer
  • 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)

Trial locations and contacts

68 sites in 7 countries.

68 sites in 7 countries

United States16 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Virginia Hospital

    Charlottesville, Virginia, 22908

  • John B. Amos Cancer Center / IACT Health

    Columbus, Georgia, 31904

  • Compassionate Cancer Care Medical Group, Inc

    Corona, California, 92879

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Investigator Clinical Research Centers of Indiana

    Indianapolis, Indiana, 46260-2082

  • Southeast Nebraska Cancer Center (SNCC) - Central Clinic - Main Clinic

    Lincoln, Nebraska, 68510

  • Charleston Cancer Center

    North Charleston, South Carolina, 29406

  • Guthrie - Corning Hospital - Guthrie Cancer Center

    Sayre, Pennsylvania, 18840-1625

  • Orchard Healthcare Research (OHR) Inc.

    Skokie, Illinois, 60077

  • Scott & White Vasicek Cancer Treatment Center

    Temple, Texas, 76508

  • Renovatioclinical

    The Woodlands, Texas, 77380

  • Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)

    Topeka, Kansas, 66606

  • North Mississippi Hematology & Oncology Associates, Ltd.

    Tupelo, Mississippi, 38801

Other trials in United States

France15 sites

  • CHU Angers

    Angers

  • CHRU - Besançon

    Besançon

  • Hopital Haut Leveque

    Bordeaux

  • CHRU Brest - Hôpital Morvan

    Brest

  • Centre Hospitalier de Cholet

    Cholet

  • Centre Georges François Leclerc

    Dijon

  • Centre Hospitalier Départemental

    La Roche-sur-Yon

  • Hôpital Privé Jean Mermoz

    Lyon

  • La Timone

    Marseille

  • Institut de Cancérologie de Lorraine

    Nancy

  • Centre Antoine-Lacassagne

    Nice

  • Hopital La Pitié Salpétrière

    Paris

  • CH Saint Jean

    Perpignan, 66046

  • Centre Eugène Marquis

    Rennes

  • Clinique Sainte Anne/Strasbourg Oncologie Leberale

    Strasbourg

Other trials in France

Taiwan10 sites

  • Changhua Christian Hospital

    Changhua

  • Chang Gung Medical Foundation - Kaohsiung Branch

    Kaohsiung City

  • E-Da Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Mackay Memorial Hospital-Taipei Branch

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital (TSGH)

    Taipei

  • Chang Gung Medical Foundation - Linkou Branch

    Taoyuan

Other trials in Taiwan

South Korea9 sites

  • Chungnam National University Hospital

    Daejeon

  • National Cancer Center

    Goyang-si

  • Inha University Hospital

    Incheon

  • Chonnam National University Hwasun Hospital

    Jeongnam

  • CHA Bundang Medical Center

    Seongnam

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Severance Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Russia7 sites

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk

  • Kursk State Clinical Oncology Dispensary

    Kursk

  • Federal State Budgetary Scientific Institution "Russian Oncological Scientific Center named after N.N.Blokhin"

    Moscow

  • Private clinnic "Medicine 24/7"

    Moscow

  • Budget Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"

    Omsk

  • State Budget Healthcare Institution "Orenburg Region Clinical Oncological Dispensary"

    Orenburg

  • State Budgetary Healthcare Institution Leningrad Regional Oncology Center

    Saint Petersburg

Other trials in Russia

Hungary6 sites

  • Dél-pesti Centrumkórház - Országos Hematológia és Infektológia Intézet

    Budapest

  • Magyar Honvédség Egészségügyi Központ

    Budapest

  • Országos Onkológiai Intézet

    Budapest

  • Bács-Kiskun Megyei Kórház Onkoradiológiai Központ

    Kecskemét

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

    Miskolc

  • Pécsi Tudomány Egyetem Onkoterápiás Intézet

    Pécs

Other trials in Hungary

Israel5 sites

  • Oncology Department, Hillel Yafe MC

    Hadera

  • Rambam Health Center

    Haifa

  • Meir Medical Center

    Kfar Saba

  • Rabin MC

    Petah Tikva

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

About this study

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

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.

Read the 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

Being tested
EndoTAG-1, Gemcitabine
Keywords
FOLFIRINOX, 5-Fluorouracil, folinic acid, irinotecan, oxaliplatin, Gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoTAG-1Drug

    Also called 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.

    twice weekly

  • GemcitabineDrug

    Also called Gemcitabine Hydrochloride

    once weekly

Study groups in NCT03126435
Study groupRoleWhat they receive
EndoTAG-1 and GemcitabineExperimentalEndoTAG-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.
Receives: Drug: EndoTAG-1; Drug: Gemcitabine
Gemcitabine MonotherapyActive comparatorGemcitabine 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.
Receives: Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    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.

    Measured: 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 outcomes (5)

  1. 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.

    Measured: From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment)

  2. Percentage of Subjects With Objective Response

    Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.

    Measured: Up to approximately 33.5 months (assessed continuously during treatment)

  3. Duration of Response

    Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30.

    Measured: 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

    Measured: Up to approximately 33.5 months (assessed continuously during treatment)

  5. 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). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments.

    Measured: Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start16 Oct 2018
  3. Primary completion30 Jul 2021
  4. Study completion8 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126435
Sponsor's protocol ID
CT4006
Status last verified
May 2023
First submitted
19 Apr 2017
Last updated
6 May 2023
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EndoTAG-1 and Gemcitabine in people with Metastatic Pancreas Cancer and Locally Advanced Pancreatic Cancer, run by SynCore Biotechnology Co., Ltd. at 68 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, France, Taiwan, South Korea, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03126435.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in