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

NCT03126435 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CT4006
• Study Type: interventional
• Target: 218
• Locations: 7 countries
• Sites: 68

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.

Conditions

Metastatic Pancreas Cancer; Locally Advanced Pancreatic Cancer; Pancreatic Adenocarcinoma

Keywords

FOLFIRINOX; 5-Fluorouracil; folinic acid; irinotecan; oxaliplatin; Gemcitabine

Outcome Measures

Primary Outcomes (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.

  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)

• Progression Free Survival (PFS)

  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 Response

  Up to approximately 33.5 months (assessed continuously during treatment)

• Duration of Response

  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.1.1

  Up to approximately 33.5 months (assessed continuously during treatment)

• Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate

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

Other Outcomes (2)

• Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score

  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) Score

  Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))

Study Arms (2)

EndoTAG-1 and Gemcitabine

EXPERIMENTAL

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; Drug: Gemcitabine

Gemcitabine Monotherapy

ACTIVE COMPARATOR

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

Interventions

EndoTAG-1 DRUG

twice weekly

Also known as: 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.

EndoTAG-1 and Gemcitabine

Gemcitabine DRUG

once weekly

Also known as: Gemcitabine Hydrochloride

EndoTAG-1 and Gemcitabine; Gemcitabine Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• SynCore Biotechnology Co., Ltd.: lead

Study Sites (68)

Compassionate Cancer Care Medical Group, Inc

Corona, California, 92879, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

John B. Amos Cancer Center / IACT Health

Columbus, Georgia, 31904, United States

Location

Orchard Healthcare Research (OHR) Inc.

Skokie, Illinois, 60077, United States

Location

Investigator Clinical Research Centers of Indiana

Indianapolis, Indiana, 46260-2082, United States

Location

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

Topeka, Kansas, 66606, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

North Mississippi Hematology & Oncology Associates, Ltd.

Tupelo, Mississippi, 38801, United States

Location

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

Lincoln, Nebraska, 68510, United States

Location

Guthrie - Corning Hospital - Guthrie Cancer Center

Sayre, Pennsylvania, 18840-1625, United States

Location

Charleston Cancer Center

North Charleston, South Carolina, 29406, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Scott & White Vasicek Cancer Treatment Center

Temple, Texas, 76508, United States

Location

Renovatioclinical

The Woodlands, Texas, 77380, United States

Location

University of Virginia Hospital

Charlottesville, Virginia, 22908, United States

Location

CHU Angers

Angers, France

Location

CHRU - Besançon

Besançon, France

Location

Hopital Haut Leveque

Bordeaux, France

Location

CHRU Brest - Hôpital Morvan

Brest, France

Location

Centre Hospitalier de Cholet

Cholet, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre Hospitalier Départemental

La Roche-sur-Yon, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

La Timone

Marseille, France

Location

Institut de Cancérologie de Lorraine

Nancy, France

Location

Centre Antoine-Lacassagne

Nice, France

Location

Hopital La Pitié Salpétrière

Paris, France

Location

CH Saint Jean

Perpignan, 66046, France

Location

Centre Eugène Marquis

Rennes, France

Location

Clinique Sainte Anne/Strasbourg Oncologie Leberale

Strasbourg, France

Location

Dél-pesti Centrumkórház - Országos Hematológia és Infektológia Intézet

Budapest, Hungary

Location

Magyar Honvédség Egészségügyi Központ

Budapest, Hungary

Location

Országos Onkológiai Intézet

Budapest, Hungary

Location

Bács-Kiskun Megyei Kórház Onkoradiológiai Központ

Kecskemét, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, Hungary

Location

Pécsi Tudomány Egyetem Onkoterápiás Intézet

Pécs, Hungary

Location

Oncology Department, Hillel Yafe MC

Hadera, Israel

Location

Rambam Health Center

Haifa, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Rabin MC

Petah Tikva, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, Russia

Location

Kursk State Clinical Oncology Dispensary

Kursk, Russia

Location

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

Moscow, Russia

Location

Private clinnic "Medicine 24/7"

Moscow, Russia

Location

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

Omsk, Russia

Location

State Budget Healthcare Institution "Orenburg Region Clinical Oncological Dispensary"

Orenburg, Russia

Location

State Budgetary Healthcare Institution Leningrad Regional Oncology Center

Saint Petersburg, Russia

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

National Cancer Center

Goyang-si, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Chonnam National University Hwasun Hospital

Jeongnam, South Korea

Location

CHA Bundang Medical Center

Seongnam, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Changhua Christian Hospital

Changhua, Taiwan

Location

Chang Gung Medical Foundation - Kaohsiung Branch

Kaohsiung City, Taiwan

Location

E-Da Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Mackay Memorial Hospital-Taipei Branch

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital (TSGH)

Taipei, Taiwan

Location

Chang Gung Medical Foundation - Linkou Branch

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

MBT-0206; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Albert Lin, Ph.D./Special Assistant to GM
• Organization: SynCore Biotechnology Co., Ltd.

JWLin@syncorebio.com

+886-2-2760-3688

Study Officials

• Li-Tzong Chen, M.D., Ph.D.

  National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: October 16, 2018
• Primary Completion: July 30, 2021
• Study Completion: October 8, 2021
• Last Updated: May 6, 2023
• Results First Posted: March 24, 2023

Record last verified: 2023-05

Locations

HU (6); RU (7); KR (9); TW (10); IL (5); FR (15); US (16)