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.

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. - NALPAC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003889-39-BE

Enrollment

134

Registered

2021-08-19

Start date

2021-10-11

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic ductal adenocarcinoma (PDAC)

Interventions

Trade Name: Onyvide (Pegylated Liposomal Irinothecan ) Pharmaceutical Form: Solution for infusion INN or Proposed INN: Nanoliposomal irinotecan Other descriptive name: PEG-IRINOTECAN Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven metastatic adenocarcinoma of the pancreas 2. Progression documented after Gemcitabine-Abraxane or gemcitabine alone 3. Signed written informed consent 4. Age = 18 5. ECOG PS 0/1 at study entry 6. Measurable disease 7. 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) 8. INR/PTT = 1.5x ULN 9. Life expectancy of at least 12 weeks 10. Effective contraception for both male and female patients if the risk of conception exists 11. Peripheral Neuropathy =65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: 1. Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension 2. History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months 3. Known hypersensitivity to any of the components of study treatments 4. Previous malignancy in the last past 3 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or carcinoma in situ of any type 5. Pregnancy or breast feeding 6. Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent 7. Unstable angina, congestive heart failure =NYHA class II 8. Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg) 9. Complete DPD deficiency 10. HIV infection 11. Liver failure, cirrhosis Child Pugh B or C 12. Active chronic hepatitis B or C with a need for antiviral treatment 13. Brain metastasis 14. Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment 15. History of organ allograft 16. Ongoing uncontrolled, serious infection 17. Renal failure requiring dialysis 18. Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study

Design outcomes

Primary

Measure	Time frame
Main Objective: 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). The PFSR is defined as the proportion of patients alive and free of progression at day 85. ;Secondary Objective: To evaluate in both treatment 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) ;Primary end point(s): PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD). ;Timepoint(s) of evaluation of this end point: PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).	—

Measure

Time frame

Main Objective: 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). The PFSR is defined as the proportion of patients alive and free of progression at day 85. ;Secondary Objective: To evaluate in both treatment 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) ;Primary end point(s): PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD). ;Timepoint(s) of evaluation of this end point: PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).

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Secondary

Measure	Time frame
Secondary end point(s): • Safety/toxicity and tolerability profile Safety/toxicity and tolerability will be assessed throughout the study by evaluating the following safety variables: o Adverse events throughout the study for which the following data are to be recorded: ? Description ? Start and stop date and time ? NCI-CTCAE v. 5 ? Grade ? Causal relationship with medication ? Action taken ? Outcome ? Seriousness ? Expectedness o Laboratory safety assessments performed as specified in 6.6.4 Lab assessments. They are mandatory prior to the administration of study medication. Tumor markers CA 19-9 and CEA are measured at baseline, every 6 weeks for 3 times, then every 8 weeks until progression or withdrawal and at the follow-up visit. o Physical examination as described at section 6.6.3 and WHO ECOG performance status (PS) • PFS and sensitivity analyses • PFS is defined as the time from Day 1 of therapy (day of first infusion of medication on study), until the first observation of disease progression according RECIST 1.1 criteria or the date of death due to any cause. • For patients who deceased more than 60 days after either the last valid tumor assessment or after the date of Day 1 of therapy without having had imaging performed, the PFS time will be censored on the date of last tumor assessment or date of Day 2 of therapy respectively. • Non-progressed patients discontinuing study treatment and not undertaking a different anti-cancer treatment will be censored for progression at the date of the last valid tumor assessment. • Non-progressed patients discontinuing study treatment and undertaking a different anti-cancer treatment will be censored for progression at the date of starting the new anti-cancer treatment. Exceptions of this rule may be applied for patients undertaking procedures that are not aimed at the main disease i.e. stenting, radiotherapy for symptom control not on target lesions, and possibly other treatments on a case by case basis • The effect	—

Measure

Time frame

Secondary end point(s): • Safety/toxicity and tolerability profile Safety/toxicity and tolerability will be assessed throughout the study by evaluating the following safety variables: o Adverse events throughout the study for which the following data are to be recorded: ? Description ? Start and stop date and time ? NCI-CTCAE v. 5 ? Grade ? Causal relationship with medication ? Action taken ? Outcome ? Seriousness ? Expectedness o Laboratory safety assessments performed as specified in 6.6.4 Lab assessments. They are mandatory prior to the administration of study medication. Tumor markers CA 19-9 and CEA are measured at baseline, every 6 weeks for 3 times, then every 8 weeks until progression or withdrawal and at the follow-up visit. o Physical examination as described at section 6.6.3 and WHO ECOG performance status (PS) • PFS and sensitivity analyses • PFS is defined as the time from Day 1 of therapy (day of first infusion of medication on study), until the first observation of disease progression according RECIST 1.1 criteria or the date of death due to any cause. • For patients who deceased more than 60 days after either the last valid tumor assessment or after the date of Day 1 of therapy without having had imaging performed, the PFS time will be censored on the date of last tumor assessment or date of Day 2 of therapy respectively. • Non-progressed patients discontinuing study treatment and not undertaking a different anti-cancer treatment will be censored for progression at the date of the last valid tumor assessment. • Non-progressed patients discontinuing study treatment and undertaking a different anti-cancer treatment will be censored for progression at the date of starting the new anti-cancer treatment. Exceptions of this rule may be applied for patients undertaking procedures that are not aimed at the main disease i.e. stenting, radiotherapy for symptom control not on target lesions, and possibly other treatments on a case by case basis • The effect

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Countries

Belgium

Contacts

Public ContactClinical Trial Coordinator

Belgian Group of Digestive Oncology (BGDO)

clinicaltrials@bgdo.org0032 0474074484

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026