A study to investigate changes in the amount of mutations in patients with Resectable Pancreatic Ductal Adenocarcinoma

Phase 1

• Conditions: Resectable Pancreatic Ductal Adenocarcinoma; MedDRA version: 20.0 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002094-22-ES
• Lead Sponsor: Fundación de investigación de HM Hospitales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Male or females, aged 18 years or older
2. Histologically or cytologically confirmed diagnosis of PDAC
3. Candidates for pancreatic cancer surgery (no cormobidities that can exclude for surgery)
4. Life expectance of at least 12 months
5. Carbohydrate antigen 19-9 (CA19-9) levels < 500 U/ml
6. ECOG performance status < or 1
7. Adequate bone marrow function
8. Adequate hepatic function
9. Adequate renal function
10. Sexually active men and women of childbearing potential must use efficient contraceptive methods. Contraceptive methods comprise: oral contraceptives, intrauterine devices, sexual abstinence, tubal ligation, IUD, barrier methods or another contraceptive considered appropriate by the investigator. Women of childbearing potential must have a negative serum pregnancy test before study entry.
11. Agree to participate and signed the ICF.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Patients with metastatic disease
2. Patients > or =75 years.
3. Uncontrolled coagulopathy
4. Patients with a contraindication to surgery (locally advanced disease or patients not
amenable to pancreatic surgery due to a previous comorbidity)
5. Patients with prior or concurrent malignant disease that required treatment with
chemotherapy in the past.
6. Previous citotoxic therapy within 36 months for other no-cancer disease (ie arthritis
rheumatoid)
7. Known or suspected reactions to any component of the study medication (5-FU/LV, nal-
IRI or oxaliplatin) or to components of similar chemical or biologic composition
8. Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule
9. Human immunodeficiency virus (HIV) positivity, active Hepatitis B or Hepatitis C
infection.
10. Uncontrolled illness including ongoing or active infection, symptomatic congestive
heart failure, unstable angina, cardiac arrhythmia, myocardial infarction, or left ventricular
ejection fraction (LVEF) < 50, among others, or psychiatric illness/social situations that
would limit compliance with study requirements.
11. Pregnant or breast-feeding women.
12. Any medical condition that, based on investigator’s criteria, places the subject at risk,
makes the subject ineligible or may jeopardize protocol compliance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified