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| Name | Class |
|---|---|
| University Hospital St Luc, Brussels | OTHER |
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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
Based on the results of previous studies, the sponsor aims to assess efficacy and safety of this triplet (irinotecan, 5FU/LV and oxaliplatin) in second-line treatment in fit patients (ECOG 0-1) metastatic PDAC.
The primary objective is to assess the efficacy of NALIRINOX (= investigational arm) and NALIRI (= standard care arm) in terms of Progression-Free Survival Rate (PFSR).
As secondary objectives, the following will be evaluated in both arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A NALIRI | Active Comparator | Cycle length: 14 days Day 1:
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| Arm B NALIRINOX | Experimental | Cycle length: 14 days Day 1:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanoliposomal irinotecan | Drug | In the control arm (Naliri) a dose of 70mg/m² is administered in combination with 5FU and leucovorin In the investigational arm (Nalirinox) a dose of 50mg/m² is administered in combination with 5FU, leucovorin and oxaliplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of NALIRINOX and NALIRI through Progression-Free Survival at D85 | NALIRINOX is the investigational arm and NALIRI is the standard care arm. The efficacy will be assessed in terms of the Progression-Free Survival Rate (PFSR). This is defined as the proportion of patients alive and free of progression at day 85. | at day 85 from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/toxicity and tolerability profil: Severety of adverse events | Adverse events and Serious Adverse events will be assessed during the study treatment and until 14 days later. Severety will be graded according to the NCI-CTCAE version 5.0 and relationship to the study medication will be defined. | until 14 days after End of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory lab investigation for potential prognostic and predictive biomarkers on blood and tumor samples | Translational research will be performed for potential prognostic and predictive biomarkers. For that purpose, plasma samples will be kept in the selected centres' biobanks. The translational research will be carried out on tumor samples collected before the start of treatment and on blood samples collected as per below. Tumor tissue: 10 slices of the paraffin embedded tissue collected during the diagnosis of the disease will be collected. Blood samples: Two 10 ml blood samples from each patient who consents to participate in the biological study will be collected before the start of the treatment, and before each cycle till the discontinuation of the treatment. The exact measurements that will be done, have not been defined yet. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Dewever | Contact | +32 (0) 479 36 63 82 | lina.dewever@bgdo.org |
| Name | Affiliation | Role |
|---|---|---|
| Ivan Borbath | University hospital St-luc, Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Antwerpen | Recruiting | Antwerp | Antwerp | 2650 | Belgium |
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| 5 FU | Drug | In the control arm (Naliri) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan and leucovorin In the investigational arm (Nalirinox) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan, leucovorin and oxaliplatin |
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| Leucovorin | Drug | In the control arm (Naliri) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan and 5FU In the investigational arm (Nalirinox) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and oxaliplatin |
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| Oxaliplatin | Drug | Only administered in the investigational arm (Nalirinox): a dose of 60 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and Leucovorin |
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| Safety/toxicity and tolerability profil: Laboratory assessments |
Standard laboratory safety assessments: They are mandatory prior to each administration of study medication and at the 15 days follow-up visit. Clinically significant vs not clinically significant. |
| until 14 days after End of Treatment |
| Safety/toxicity and tolerability profil: ECOG | WHO ECOG performance status (PS) will be defined prior to each administration of study medication and at the 15 days follow-up visit following the ECOG Performance Status Scale. | until 14 days after End of Treatment |
| Safety/toxicity and tolerability profil: review of body systems | A full review of body systems will be performed: heart rate, blood pressure, respiratory rate, body temperature, height, weight and ECG (screening visit only, unless clinically indicated). Clinically significant versus not clinically significant | until 14 days after End of Treatment |
| Progression Free Survival and sensitivity analysis: Effect of Center on prognostic factors | The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
| From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment. |
| Progression Free Survival and sensitivity analysis: Effect of tumor location on prognostic factors | The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
| From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment |
| Progression Free Survival and sensitivity analysis: Effect of previous chemotherapy on prognostic factors | The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
| From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment |
| Progression Free Survival and sensitivity analysis: effect of ECOG on prognostic factors | The effect of potential prognostic factors will be assessed through sensitivity analyses, including:
| From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment |
| Objective tumor response: Rate of complete response and partial response | Tumor (response) evaluation will be performed according to RECIST criteria v. 1.1 (CT scan thorax, abdomen and pelvis or MRI abdomen and pelvis + CT chest) based upon the investigator's assessment. Overall response is defined as a best response of either CR or PR (CR+PR). | performed within 28 days before start therapy, 3 times every 6 weeks and afterwards every 8 weeks |
| Duration of overall survival | For patients who are still alive at the time of study analysis or who are lost to follow up, survival will be censored at the last recorded date that the patient is known to be alive or at the date of data cut-off, whatever occurs earlier. | Time from Day 1 of therapy to death until maximum 5 years after End of Treatment |
| Duration of disease control | Disease control is defined as a best response of either CR, PR, or SD (CR+PR+SD). | From date of first study treatment administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years after End of Treatment |
| Duration of response | The duration of response will be censored on the date of last known tumor assessment for not progressed patients lost to follow up or deceased prior to the next planned tumor assessment (within 60 days). Not evaluable patients at one time point assessment will be censored at the date of last known assessment. | Time from measurement criteria are first met for CR/PR to either the first time disease progression is documented or death (for not progressed patients who deceased within 60 days from last tumor assessment) until maximum 5 years after EOT |
| Sapmples will be collected throughout the study and shipped to the sponsor maximum 1 year after last 15 day follow-up visit |
| ULB Erasme | Recruiting | Brussels | Brussels Capital | 1070 | Belgium |
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| Cliniques Universitaires Saint-Luc UCL | Recruiting | Brussels | Brussels Capital | 1200 | Belgium |
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| CHC MontLégia | Recruiting | Liège | Liège | 4000 | Belgium |
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| AZ St-Lucas | Not yet recruiting | Bruges | West-Vlaanderen | Belgium |
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| AZ Imelda | Recruiting | Bonheiden | Belgium |
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| Grand Hopital de Charleroi | Recruiting | Charleroi | Belgium |
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| AZ Maria Middelares | Recruiting | Ghent | Belgium |
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| University Hospital Ghent | Recruiting | Ghent | Belgium |
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| Pôle Hospitalier Jolimont (HELORA) | Recruiting | Haine-Saint-Paul | 7100 | Belgium |
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| CHU Ambroise Paré | Recruiting | Mons | Belgium |
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| CHR Namur | Recruiting | Namur | Belgium |
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| AZ Turnhout | Recruiting | Turnhout | 2300 | Belgium |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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