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2022-05-25
2026-12-31
2027-12-31
134
NCT05472259
Belgian Group of Digestive Oncology
Belgian Group of Digestive Oncology
INTERVENTIONAL
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
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: * Safety/toxicity and tolerability profile according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5. * Progression free survival (PFS) * Overall response rate and duration of response as assessed by imaging (RECIST 1.1) and tumor markers * Overall survival (OS)
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-12-09 | N/A | 2025-02-04 |
2022-07-22 | N/A | 2025-02-06 |
2022-07-25 | N/A | 2024-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Arm A NALIRI Cycle length: 14 days Day 1: * Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours * Liposomal irinotecan (FBE): 70 mg/m² IV* - Dilute in 500 mL DSW and administer over 90 min * 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0, | DRUG: Nanoliposomal irinotecan
DRUG: 5 FU
DRUG: Leucovorin
|
| EXPERIMENTAL: Arm B NALIRINOX Cycle length: 14 days Day 1: * Oxaliplatin 60 mg IV - Dilute in 500 mL D5W and administer over two hours (prior to leucovorin). Shorter oxaliplatin administration schedules (eg. 1mg/m2 per minute) appear to be safe. * Leucovorin: 400 mg/m² IV - Dilute i | DRUG: Nanoliposomal irinotecan
DRUG: 5 FU
DRUG: Leucovorin
DRUG: Oxaliplatin
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 |
| 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: * Investigational Center | 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: * Location of tumor (head of the pancreas versus other location) | 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: * Previous chemotherapy: gemcitabine alone vs gem-abx | 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: * WHO ECOG performance status (0 versus 1) | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Lina Dewever Phone Number: +32 (0) 479 36 63 82 Email: lina.dewever@bgdo.org |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
