Last updated on April 2020

EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: FOLFIRINOX | Islet Ce417ll Cancer | Pancreatic Cancer | Metastatic Pancreas Cancer | Locally Advanced Pancreatic Cancer | Pancreatic Adenocarcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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:
  9. WBC 3 x 10/mm
  10. ANC 1.5 x 10/mm
  11. Platelets 100.000/mm
  12. Hb 9.0 g/dl ( 5.6 mmol/l)
  13. aPTT > 1.5 x ULN
  14. Serum creatinine > 2.0 mg/dl (> 176.8 mol/l)
  15. AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
  16. Alkaline phosphatase > 2.5 x ULN
  17. Total bilirubin > 2 x ULN
  18. Albumin < 2.5 g/dL
  19. Clinically significant ascites
  20. 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.
  21. Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field
  22. Major surgery < 4 weeks prior to enrollment
  23. Pregnant or nursing
  24. Investigational medicinal product < 4 weeks of enrollment
  25. Documented HIV history
  26. 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.
  27. Known hypersensitivity to any component of the EndoTAG-1 and/or gemcitabine formulations
  28. 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
  29. Vulnerable populations (e.g. subjects unable to understand and give voluntary informed consent)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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