Evaluating new treatment combinations for metastatic pancreatic cancer
A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy
This study is testing two new treatment combinations for people with advanced pancreatic cancer to see if they can help patients live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Belgian Group of Digestive Oncology Academic / other |
| Locations | 13 sites (Antwerp, Antwerp and 12 other locations) |
| Trial ID | NCT05472259 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial aims to evaluate the efficacy and safety of two treatment combinations, 5-FU + NALIRI and 5-FU + NALIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after previous therapies. The study will assess the primary outcome of progression-free survival rate, along with secondary outcomes including overall survival and safety profiles. Eligible participants must have measurable disease and meet specific health criteria, ensuring they are fit for treatment. The trial is designed to provide insights into the effectiveness of these combinations in a challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically proven metastatic pancreatic adenocarcinoma who have experienced disease progression after prior treatments.
Not a fit: Patients with uncontrolled concurrent diseases or significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment option for patients with advanced pancreatic cancer.
How similar studies have performed: Previous studies have shown promise with similar treatment approaches, but this specific combination is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven metastatic adenocarcinoma of the pancreas * Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy * Signed written informed consent * Age ≥ 18 * ECOG PS 0/1 at study entry * Measurable disease * Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl) * INR/PTT ≤ 1.5x ULN * Life expectancy of at least 12 weeks * Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration * Peripheral Neuropathy \< grade 2 Exclusion Criteria: * Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension * History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months * Known hypersensitivity to any of the components, including excipients, of study treatments * Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type * Pregnancy or breast feeding * Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent * Unstable angina, congestive heart failure ≥NYHA class II * Uncontrolled hypertension despite optimal management (systolic blood pressure \>150 mmHg or diastolic pressure \> 90mmHg) * HIV infection * Complete DPD deficiency * Liver failure, cirrhosis Child Pugh B or C * Active chronic hepatitis B or C with a need for antiviral treatment * Brain metastasis * Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment * History of organ allograft * Ongoing uncontrolled, serious infection * Renal failure requiring dialysis * Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study
Where this trial is running
Antwerp, Antwerp and 12 other locations
- UZ Antwerpen — Antwerp, Antwerp, Belgium (Recruiting)
- ULB Erasme — Brussels, Brussels Capital, Belgium (Recruiting)
- Cliniques Universitaires Saint-Luc UCL — Brussels, Brussels Capital, Belgium (Recruiting)
- CHC MontLégia — Liège, Liège, Belgium (Recruiting)
- AZ St-Lucas — Bruges, West-Vlaanderen, Belgium (Not_yet_recruiting)
- AZ Imelda — Bonheiden, Belgium (Recruiting)
- Grand Hopital de Charleroi — Charleroi, Belgium (Recruiting)
- AZ Maria Middelares — Ghent, Belgium (Recruiting)
- University Hospital Ghent — Ghent, Belgium (Recruiting)
- Pôle Hospitalier Jolimont (HELORA) — Haine-Saint-Paul, Belgium (Recruiting)
- CHU Ambroise Paré — Mons, Belgium (Recruiting)
- CHR Namur — Namur, Belgium (Recruiting)
- AZ Turnhout — Turnhout, Belgium (Recruiting)
Study contacts
- Principal investigator: Ivan Borbath — University hospital St-luc, Brussel
- Study coordinator: Lina Dewever
- Email: lina.dewever@bgdo.org
- Phone: +32 (0) 479 36 63 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.