- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03043547
Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies (NALIRICC)
May 17, 2022 updated by: AIO-Studien-gGmbH
A Randomized Phase II Trial of Nal-IRI and 5-Fluorouracil Compared to 5-Fluorouracil in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies
is an open label, randomized, multicenter phase II trial
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective is to assess the efficacy of nal-IRI in gemcitabine pre-treated patients with advanced, unresectable and metastatic cholangio- and gallbladder carcinoma eligible for treatments after failure to respond to a gemcitabine-based treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
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
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Hannover, Germany, 30625
- Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent incl. 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
- Age ≥ 18 years at time of study entry
- Histologically or cytologically confirmed, non-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma
- Measurable or assessable disease according to RECIST 1.1
Documented disease progression after prior gemcitabine or gemcitabine containing therapy, in locally advanced or metastatic setting. Examples of permitted therapies include, but are not limited to:
- Single agent gemcitabine
- Any one gemcitabine-based regimen, with or without maintenance gemcitabine
- ECOG performance status 0-1
Adequate blood count, liver-enzymes, and renal function:
- ANC > 1,500 cells/μL without the use of hematopoietic growth factors; and
- Platelet count ≥ 100 x 10^9/L (>100,000 per mm³) and
- Hemoglobin > 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)
- Serum total bilirubin ≤ 3x upper normal limit (ULN) (biliary drainage is allowed for biliary obstruction; elevated bilirubin should be caused by obstruction not impaired liver function as assessed by albumin and INR values):
- Albumin levels ≥ 3.0 g/dL
- Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and PTT < 1.5 ULN within 7 days prior to randomization. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of randomization
- AST (SGOT)/ALT (SGPT) ≤ 5 x institutional upper limit of normal
- Serum Creatinine ≤ 1.5 x ULN and a calculated glomerular filtration rate ≥ 30 mL per minute
- Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of treatment.
- Subject is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion Criteria:
- Active CNS metastases (indicated by clinical symptoms, cerebral oedema, steroid requirement, or progressive disease); patient should have been off steroids for at least 28 days prior to starting study therapy
- Clinically significant gastrointestinal disorder including bleeding, inflammation, occlusion, or diarrhoea > grade 1
- History of any second malignancy in the last 5 years; subjects with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years.
- Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumour fever may be enrolled), which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome.
- Premalignant hematologic disorders, e.g. myelodysplastic syndrome
- Pre-existing lung disease
- Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
- History of hypersensitivity to any of the study drugs or any excipient (nal-IRI, other liposomal products, fluoropyrimidines or leucovorin)
- 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, nor significant traumatic injury within 28 days prior to randomization, 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.
- Medication that is known to interfere with any of the agents applied in the trial.
- 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 pessaries (only hormonal devices), sexual abstinence or vasectomy of the partner].
- Known Gilbert-Meulengracht syndrome
- 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
- Participation in another clinical study with an investigational product during the last 30 days before inclusion or 5 half-lifes of previously used trial medication, whichever is of longer duration.
- Previous enrollment or randomization in the present study (does not include screening failure).
- Previous enrollment in the NIFE trial [AIO-YMO/HEP-0315]
- Involvement in the planning and/or conduct of the study (applies to both Baxalta staff and/or staff of sponsor and study site)
- Patient who might be dependent on the sponsor, site or the investigator
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
- 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nal-IRI + 5-FU + leucovorin (Arm A)
nal-IRI [Irinotecan liposome] (80 mg/m2 as a 1.5 hour infusion), 5-FU [5-Fluorouracil] (2400 mg/m2 as 46 hour infusion) and leucovorin (400 mg/m2 as 0.5 hour infusion) (q2w)
|
nal-IRI [Irinotecan liposome] (80 mg/m2 as a 1.5 hour infusion)
5-FU [5-Fluorouracil] (2400 mg/m2 as 46 hour infusion)
leucovorin (400 mg/m2 as 0.5 hour infusion)
|
Other: 5-FU + leucovorin (Arm B)
Control intervention/standard arm: 5-FU (2400 mg/m2 as 46 hour infusion) and leucovorin (400 mg/m2 as 0.5 hour infusion) (q2w)
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5-FU [5-Fluorouracil] (2400 mg/m2 as 46 hour infusion)
leucovorin (400 mg/m2 as 0.5 hour infusion)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: approx 42 months
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approx 42 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: approx 42 months
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approx 42 months
|
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Objective tumor response rate (ORR) according to RECIST 1.1
Time Frame: approx 42 months
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Response Evaluation Criteria in Solid Tumors (RECIST 1.1.)
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approx 42 months
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Toxicity/Safety
Time Frame: approx 42 months
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according to Common Terminology Criteria for Adverse Events
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approx 42 months
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Health related Quality of Life
Time Frame: approx 42 months
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EORTC QLQ-C30
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approx 42 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
biomarkers
Time Frame: approx 42 months
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Ca-19-9, CEA, CRP serum levels
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approx 42 months
|
Immunohistochemistry of Carboxylesterase (CES)
Time Frame: approx 42 months
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approx 42 months
|
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Analyse whole blood
Time Frame: approx 42 months
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will be collected to potentially identify factors that may correlate with tumour response, sensitivity or resistance to nal-IRI
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approx 42 months
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Analyse plasma
Time Frame: approx 42 months
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will be collected to potentially identify factors that may correlate with tumour response, sensitivity or resistance to nal-IRI
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approx 42 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Arndt Vogel, Prof., Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 24, 2017
Primary Completion (Actual)
December 8, 2021
Study Completion (Actual)
March 8, 2022
Study Registration Dates
First Submitted
January 26, 2017
First Submitted That Met QC Criteria
February 2, 2017
First Posted (Estimate)
February 6, 2017
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIO-HEP-0116
- 2016-003709-33 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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