AzTrials
AzTrials

Locally Advanced Pancreatic CancerPhase 3PREDICTNCT03468335

2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

A Phase 3 study testing Irinotecan Liposomal Injection [Onivyde] in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by AIO-Studien-gGmbH at 35 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Second-line therapy with Nal-IRI after failure gemcitabine/nab-paclitaxel in advanced pancreatic cancer - predictive role of 1st-line therapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Irinotecan Liposomal Injection [Onivyde]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
35 sitesGermany
Study dates
31 Mar 2018to 31 May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent including participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  • Clinical indication for a 2nd-line systemic therapy according to current standard-of-care.
  • Age ≥ 18 years at time of study entry
  • Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma
  • Imaging of evaluable lesions within 2 weeks of inclusion (either sonography, X-ray, CT scans, MRI)
  • ECOG performance status 0-2
Show all 15Show fewer
  • One line of systemic gemcitabine/Nab-paclitaxel -based therapy for advanced disease (irrespective of prior adjuvant therapy) OR Previous adjuvant gemcitabine/Nab-paclitaxel-based chemotherapy with documented progression less than 6 months after termination
  • Detailed documentation of prior therapy (duration, dose-intensity, maximum toxicity, reason for discontinuation)
  • Adequate blood count, liver-enzymes, and renal function:
  • neutrophil count > 1.5 x 10^6/mL
  • Platelet count ≥ 100 x 10^9/L (≥100,000 per mm^3)
  • AST (SGOT)/ALT (SGPT) ≤ 5 x institutional upper limit of normal
  • bilirubin ≤1.5 ULN (<3 x ULN in patients with confirmed mechanical cholestasis)
  • Creatinine Clearance CLcr ≥ 30 mL/min
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • Medical criteria:
  • Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
  • Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes
  • Premalignant hematologic disorders, e.g. myelodysplastic syndrome
  • Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
  • Prior (<3 years) or concurrent malignancy (other than biliary-tract cancer) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial urinary bladder tumor [Ta, Tis and T1].
Show all 34Show fewer
  • Pre-existing lung disease of clinical significance or with impact on performance status
  • History or clinical evidence of CNS metastases
  • Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria:
  • are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of study treament. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases
  • Allogeneic transplantation requiring immunosuppressive therapy or other major immunosuppressive therapy
  • Severe non-healing wounds, ulcers or bone fractions
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedures, except open biopsy, or significant traumatic injury within 28 days prior to star of study treatment, or anticipation of the need for major surgical procedure during the course of the study except for surgery of central intravenous line placement for chemotherapy administration.
  • Known Gilbert-Meulengracht syndrome
  • Known chronic hypoacusis, tinnitus or vertigo
  • Bone marrow depression (e.g., after radiation therapy)
  • Pernicious anemia and other megaloblastic anemias secondary to vitamin B12 deficiency
  • Severe impairment of hepatic function
  • Diarrhea
  • Drug related criteria:
  • Medication that is known to interfere with any of the agents applied in the trial.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • History of hypersensitivity to any of the study drugs or any of the constituents of the products.
  • Any other efficacious cancer treatment except protocol specified treatment at study start.
  • Safety criteria:
  • Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (urine or serum β-HCG acc. to SOC) at Screening.
  • Methodological criteria:
  • Any experimental pretreatment for advanced disease
  • Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.
  • Previous enrollment in the present study (does not include screening failure).
  • Regulatory and ethical criteria:
  • Patient who might be dependent on the sponsor, site or the investigator
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Germany35 sites

  • Klinikum St. Marien Amberg

    Amberg, 92224

  • HELIOS Klinikum Bad Saarow

    Bad Saarow, 15526

  • Hämatologisch-Onkologische Gemeinschaftspraxis

    Bad Soden, 65812

  • St.Josef-Hospital Klinikum der Ruhr-Universität Bochum

    Bochum, 44791

  • Städtisches Klinikum Brandenburg

    Brandenburg, 14770

  • MVZ Klinikum Coburg GmbH

    Coburg, 96450

  • Uniklinikum Köln GmbH

    Cologne, 50937

  • Donauisar Klinikum

    Deggendorf, 94469

  • BAG Onkologische Gemeinschaftspraxis Dresden

    Dresden, 01307

  • MVZ Onkologische Kooperation Harz

    Goslar, 38642

  • Medi Projekt

    Hanover, 30171

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • DRK-Kliniken Nordhessen

    Kassel, 34121

  • St. Elisabeth-Krankenhaus GmbH

    Köln - Hohenlind, 50935

  • Klinikum Landshut gGmbH

    Landshut, 84034

  • Onkopraxis Probstheida

    Leipzig, 04289

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Uniklinikum Marburg

    Marburg, 35043

  • Krankenhaus Neuperlach

    München, 81737

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Ambulantes Therapiezentrum Hämatologie / Onkologie

    Offenburg, 77654

  • Pius-Hospital

    Oldenburg, 26121

  • Studienzentrum Onkologie Ravensburg

    Ravensburg, 88212

  • Elblandklinikum Riesa

    Riesa, 01589

  • Klinikum Südstadt Rostock

    Rostock, 18059

  • Caritas-Klinik St. Theresia

    Saarbrücken, 66113

  • Diakonie Klinikum gGmbH

    Schwäbisch Hall, 74523

  • Leopoldina Krankenhaus

    Schweinfurt, 97422

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Schwarzwald-Baar-Klinikum

    Villingen-Schwenningen, 78052

  • Kliniken Nordoberpfalz Klinikum Weiden

    Weiden, 92637

  • Medizinische Studiengesellschaft Onkologie Nord-West GmbH

    Westerstede, 26655

  • St. Josefs-Hospital

    Wiesbaden, 65189

  • Hämatologisch-Onkologische Praxis Würselen

    Würselen, 52146

Other trials in Germany

About this study

Official title: Second-line Therapy With Nal-IRI After Failure Gemcitabine/Nab-paclitaxel in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

Second-line therapy with Nal-IRI after failure gemcitabine/nab-paclitaxel in advanced pancreatic cancer - predictive role of 1st-line therapy

Read the detailed description

Research hypothesis:

Patients profit from 2nd-line therapy with Nal-IRI if they also had a benefit from 1st-line treatment. Benefit from treatment (either 1st or 2nd-line) will be defined as a patient specific Time-To-Treatment Failure (TTF) which is in the upper third of the distribution of TTF values of the studied population.

Being tested
Irinotecan Liposomal Injection [Onivyde]
Keywords
Second-line therapy, Nal-IRI, failure gemcitabine/nab-paclitaxel, predictive role of 1st-line therapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irinotecan Liposomal Injection [Onivyde]Drug

    Also called Nal-IRI

    Cancer treatment for PDAC:

    • Nal-IRI (4.3 mg/ml) 70 mg/m2 as 1.5 hour infusion
    • 5-FU 2400 mg/m2 as 46 hour infusion
    • Folinic acid 400 mg/m2 as 0.5 hour infusion
    • all on D1 of each cycle; Cycle q2w ± 5 days

    Treatment until progressive disease or intolerable toxicity or withdrawal of consent.

Study groups in NCT03468335
Study groupRoleWhat they receive
Single ArmOtherCancer treatment for PDAC: * Nal-IRI (4.3 mg/ml) 70 mg/m2 as 1.5 hour infusion * 5-FU 2400 mg/m2 as 46 hour infusion * Folinic acid 400 mg/m2 as 0.5 hour infusion * all on D1 of each cycle; Cycle q2w ± 5 days Treatment until progressive disease or intolerable toxicity or withdrawal of consent.
Receives: Drug: Irinotecan Liposomal Injection [Onivyde]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Treatment Failure of second-line treatment (TTF2)

    Time-To-Treatment-Failure - (TTF2) is defined as date of signed ICF until permanent treatment discontinuation (or day of initially planned next cycle) due to progressive disease or unacceptable toxicity.

    Expected increase of the TTF2 by 50% in the cohort of patients with favorable TTF1 (TTF1 high: upper third of the patient population) as compared to patients with short TTF1 (TTF low: lowest third of the patient population)

    Measured: up to 6 month

Secondary outcomes (8)

  1. Overall survival (OS)

    Survival will be calculated from the date ICF signature until the date of death from any cause. If no event is observed (e.g. lost to follow-up) OS is censored at the day of last subject contact.

    Measured: up to 12 month

  2. Progression Free Survival (PFS)

    PFS is defined as the number of months from the date of first dose of 2nd-line treatment to the date of death or investigator assessed progression (by any imaging techique), whichever occurred earlier. If neither death nor progression is observed during the study, PFS data will be censored at the last valid tumor assessment.

    Measured: up to 12 month

  3. AEs / SAEs

    The Safety Population is the primary population for the evaluation of treatment administration/compliance and all safety data and will comprise all patients enrolled who received at least one dose of study medication. Patients will be analyzed according to the treatment actually received.

    Measured: up to 12 month

  4. Quality of Life (QoL) EORTC QLQ-C30

    Helath related Quality of Life will be evaluated with:

    • EORTC QLQ-C30

    Measured: up to 6 month

  5. Quality of Life (QoL) EORTC QLQ-PAN26

    Helath related Quality of Life will be evaluated with:

    • EORTC QLQ-PAN26

    Measured: up to 6 month

  6. Quality of Life (QoL) EORTC EQ-5D-5L

    Helath related Quality of Life will be evaluated with:

    • EORTC EQ-5D-5L

    Measured: up to 6 month

  7. Evaluation of time to definitive deterioration of QoL (TDD)

    Time to QoL deterioration is defined as a loss of ≥ 10 points in the EORTC QLQ-C30 compared to base-line.

    Measured: from date of baseline Scrore until date QoL Score deterioration, assessed up to 12 month

  8. Growth modulation index (GMI)

    The ratio of time to progression with the nth-line (TTP(n)) of therapy to the TTP(n-1) with the n-1th-line. GMI >1.33 is considered as a sign of activity in phase II trials.

    Measured: up to 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2018
  2. Study start31 Mar 2018
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single arm, multicenter phase IIIb trial
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468335
Sponsor's protocol ID
AIO-PAK-0216
Acronym
PREDICT
Status last verified
Apr 2025
First submitted
19 Jan 2018
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lutz MP, Ansorge N, Barmashenko G, Bauer H, Burkart C, Decker T, Ettrich T, Fischer von Weikersthal L, Geer T, Gerhardt A, Hofling S, Jacobasch L, Koenigsmann M, Leidig T, Plentz R, Rath S, Reichert D, Schulte M, Schulte N, Schwarzer A, Siegler G, Waldschmidt D, Karthaus M. Predictive criteria for overall survival and treatment duration of 2nd-line chemotherapy in patients with advanced pancreatic adenocarcinoma (AIO-PAK-0216). Br J Cancer. 2026 Jan;134(1):85-91. doi: 10.1038/s41416-025-03188-x. Epub 2025 Oct 14.

    PubMed 41087530

  • Lahusen A, Lutz MP, Fang R, Kirchner M, Albus S, Kluck K, Karthaus M, Schwarzer A, Siegler G, Kleger A, Ettrich TJ, Becher A, Hofling S, Siveke JT, Budczies J, Tannapfel A, Stenzinger A, Cheung PF, Eiseler T, Seufferlein T. An immune responsive tumor microenvironment imprints into PBMCs and predicts outcome in advanced pancreatic cancer: lessons from the PREDICT trial. Mol Cancer. 2025 Jul 22;24(1):202. doi: 10.1186/s12943-025-02406-7.

    PubMed 40696453

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irinotecan Liposomal Injection [Onivyde] in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by AIO-Studien-gGmbH at 35 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Treatment Failure of second-line treatment (TTF2) (time frame: up to 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03468335, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in