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

April 15, 2025 updated by: AIO-Studien-gGmbH

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Amberg, Germany, 92224
        • Klinikum St. Marien Amberg
      • Bad Saarow, Germany, 15526
        • Helios Klinikum Bad Saarow
      • Bad Soden, Germany, 65812
        • Hämatologisch-Onkologische Gemeinschaftspraxis
      • Bochum, Germany, 44791
        • St.Josef-Hospital Klinikum der Ruhr-Universität Bochum
      • Brandenburg, Germany, 14770
        • Städtisches Klinikum Brandenburg
      • Coburg, Germany, 96450
        • MVZ Klinikum Coburg GmbH
      • Deggendorf, Germany, 94469
        • DONAUISAR Klinikum
      • Dresden, Germany, 01307
        • BAG Onkologische Gemeinschaftspraxis Dresden
      • Goslar, Germany, 38642
        • MVZ Onkologische Kooperation Harz
      • Hannover, Germany, 30171
        • Medi Projekt
      • Homburg, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • Kassel, Germany, 34121
        • DRK-Kliniken Nordhessen
      • Köln, Germany, 50937
        • Uniklinikum Köln GmbH
      • Köln - Hohenlind, Germany, 50935
        • St. Elisabeth-Krankenhaus GmbH
      • Landshut, Germany, 84034
        • Klinikum Landshut gGmbH
      • Leipzig, Germany, 04289
        • Onkopraxis Probstheida
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • Mannheim, Germany, 68167
        • Universitätsmedizin Mannheim
      • Marburg, Germany, 35043
        • Uniklinikum Marburg
      • München, Germany, 81737
        • Krankenhaus Neuperlach
      • Nürnberg, Germany, 90419
        • Klinikum Nürnberg Nord
      • Offenburg, Germany, 77654
        • Ambulantes Therapiezentrum Hämatologie / Onkologie
      • Oldenburg, Germany, 26121
        • Pius-Hospital
      • Ravensburg, Germany, 88212
        • Studienzentrum Onkologie Ravensburg
      • Riesa, Germany, 01589
        • Elblandklinikum Riesa
      • Rostock, Germany, 18059
        • Klinikum Südstadt Rostock
      • Saarbrücken, Germany, 66113
        • Caritas-Klinik St. Theresia
      • Schweinfurt, Germany, 97422
        • Leopoldina Krankenhaus
      • Schwäbisch Hall, Germany, 74523
        • Diakonie Klinikum gGmbH
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
      • Villingen-Schwenningen, Germany, 78052
        • Schwarzwald-Baar-Klinikum
      • Weiden, Germany, 92637
        • Kliniken Nordoberpfalz Klinikum Weiden
      • Westerstede, Germany, 26655
        • Medizinische Studiengesellschaft Onkologie Nord-West GmbH
      • Wiesbaden, Germany, 65189
        • St. Josefs-Hospital
      • Würselen, Germany, 52146
        • Hämatologisch-Onkologische Praxis Würselen

Participation Criteria

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Clinical indication for a 2nd-line systemic therapy according to current standard-of-care.
  3. Age ≥ 18 years at time of study entry
  4. Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma
  5. Imaging of evaluable lesions within 2 weeks of inclusion (either sonography, X-ray, CT scans, MRI)
  6. ECOG performance status 0-2
  7. 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
  8. Detailed documentation of prior therapy (duration, dose-intensity, maximum toxicity, reason for discontinuation)

  9. 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
  10. 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.

Exclusion Criteria:

Medical criteria:

  1. 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:

    1. Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes
    2. Premalignant hematologic disorders, e.g. myelodysplastic syndrome
    3. Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
    4. 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].
    5. Pre-existing lung disease of clinical significance or with impact on performance status

    6. History or clinical evidence of CNS metastases

      Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria:

      I. 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

    7. Allogeneic transplantation requiring immunosuppressive therapy or other major immunosuppressive therapy
    8. Severe non-healing wounds, ulcers or bone fractions
    9. Evidence of bleeding diathesis or coagulopathy
    10. 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.
    11. Known Gilbert-Meulengracht syndrome
    12. Known chronic hypoacusis, tinnitus or vertigo
    13. Bone marrow depression (e.g., after radiation therapy)
    14. Pernicious anemia and other megaloblastic anemias secondary to vitamin B12 deficiency
    15. Severe impairment of hepatic function
    16. Diarrhea

    Drug related criteria:

  2. Medication that is known to interfere with any of the agents applied in the trial.
  3. Known dihydropyrimidine dehydrogenase (DPD) deficiency
  4. History of hypersensitivity to any of the study drugs or any of the constituents of the products.

  5. Any other efficacious cancer treatment except protocol specified treatment at study start.

    Safety criteria:

  6. 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:

  7. Any experimental pretreatment for advanced disease
  8. 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.

  9. Previous enrollment in the present study (does not include screening failure).

    Regulatory and ethical criteria:

  10. Patient who might be dependent on the sponsor, site or the investigator
  11. 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].

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single Arm

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.
Drug: Irinotecan Liposomal Injection [Onivyde]

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.

Other Names:
  • Nal-IRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Treatment Failure of second-line treatment (TTF2)
Time Frame: up to 6 month

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)
up to 6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 12 month
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.
up to 12 month
Progression Free Survival (PFS)
Time Frame: up to 12 month
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.
up to 12 month
AEs / SAEs
Time Frame: up to 12 month
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.
up to 12 month
Quality of Life (QoL) EORTC QLQ-C30
Time Frame: up to 6 month

Helath related Quality of Life will be evaluated with:

- EORTC QLQ-C30
up to 6 month
Quality of Life (QoL) EORTC QLQ-PAN26
Time Frame: up to 6 month

Helath related Quality of Life will be evaluated with:

- EORTC QLQ-PAN26
up to 6 month
Quality of Life (QoL) EORTC EQ-5D-5L
Time Frame: up to 6 month

Helath related Quality of Life will be evaluated with:

- EORTC EQ-5D-5L
up to 6 month
Evaluation of time to definitive deterioration of QoL (TDD)
Time Frame: from date of baseline Scrore until date QoL Score deterioration, assessed up to 12 month
Time to QoL deterioration is defined as a loss of ≥ 10 points in the EORTC QLQ-C30 compared to base-line.
from date of baseline Scrore until date QoL Score deterioration, assessed up to 12 month
Growth modulation index (GMI)
Time Frame: up to 6 month
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.
up to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AIO-Studien-gGmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Servier Deutschland GmbH
Crolll Gmbh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manfred P. Lutz, Prof. Dr., m.lutz@caritasklinikum.de

Study record dates

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIO-PAK-0216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Pancreatic Cancer

Clinical Trials on Irinotecan Liposomal Injection [Onivyde]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings