EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
Completed · Phase 3
Conditions studied: Metastatic Pancreas Cancer, Locally Advanced Pancreatic Cancer, Pancreatic Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT03126435
- Run by
- SynCore Biotechnology Co., Ltd.
- People needed
- 218
- Starts
- 2018-10-16
- Expected to finish
- 2021-10-08
- Last updated by the study team
- 2023-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Emory University Hospital — Atlanta, Georgia, United States
- John B. Amos Cancer Center / IACT Health — Columbus, Georgia, United States
- Orchard Healthcare Research (OHR) Inc. — Skokie, Illinois, United States
- Investigator Clinical Research Centers of Indiana — Indianapolis, Indiana, United States
- Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center) — Topeka, Kansas, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- North Mississippi Hematology & Oncology Associates, Ltd. — Tupelo, Mississippi, United States
- Southeast Nebraska Cancer Center (SNCC) - Central Clinic - Main Clinic — Lincoln, Nebraska, United States
- Guthrie - Corning Hospital - Guthrie Cancer Center — Sayre, Pennsylvania, United States
- Charleston Cancer Center — North Charleston, South Carolina, United States
- The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States
- Scott & White Vasicek Cancer Treatment Center — Temple, Texas, United States
- Renovatioclinical — The Woodlands, Texas, United States
- University of Virginia Hospital — Charlottesville, Virginia, United States
- CHU Angers — Angers, France
- CHRU - Besançon — Besançon, France
- Hopital Haut Leveque — Bordeaux, France
- CHRU Brest - Hôpital Morvan — Brest, France
- Centre Hospitalier de Cholet — Cholet, France
- Centre Georges François Leclerc — Dijon, France
- Centre Hospitalier Départemental — La Roche-sur-Yon, France
- Hôpital Privé Jean Mermoz — Lyon, France
- La Timone — Marseille, France
- Compassionate Cancer Care Medical Group, Inc — Corona, California, United States
Full record on ClinicalTrials.gov
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