BridgeMD
Study to compare 2 chemotherapy, one with Irinotecan liposome injection in addition to combination of chemotherapy and one with standard chemotherapy in patients with pancreatic cancer
EU CTIS ID: 2024-518303-21-00
What this study is testing
The primary objective of this study is to evaluate the efficacy of the regimen of irinotecan liposome injection + oxaliplatin + 5 fluorouracil (5-FU)/leucovorin (LV) versus nab paclitaxel + gemcitabine in improving overall survival (OS) in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed Informed Consent Form
- Electrocardiogram without any clinically significant findings
- Adequate coagulation: prothrombin time and partial thromboplastin time within normal limits (≤1.5 x ULN)
- No clinically significant abnormalities in urinalysis results
- Subjects infected with HIV are eligible if they meet all the following criteria: (a) CD4 count is ≥350 cells/uL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications (b) Probable long-term survival with HIV if cancer were not present (c) Stable on a highly active antiretroviral therapy (HAART) regimen for ≥4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study (d) HIV is not multi-drug resistant (e) Taking medication and/or receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication
- ≥18 years; Females of child-bearing potential must test negative for pregnancy at the time of screening and must agree to use a highly effective method of birth control; Male subjects must agree to use condoms
You likely can't join if
- Any other medical or social condition deemed by the investigator to be likely to interfere with a subject’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or any components of 5-FU, LV or oxaliplatin.
- Known hypersensitivity to any of the components of nab-paclitaxel or gemcitabine
- Concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease, including: (a) Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening (b) High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year prior to screening (c) New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure (d) Known historical or active infection with hepatitis B, or active infection with hepatitis C
- Active infection or an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing , which in the investigator’s opinion might compromise the subject’s participation in the study or affect the study outcome.
- Unwilling or unable to comply with study procedures and/or study visits, including long-term follow-up for survival.
See the full eligibility criteria
Who can join
- Signed Informed Consent Form
- Electrocardiogram without any clinically significant findings
- Adequate coagulation: prothrombin time and partial thromboplastin time within normal limits (≤1.5 x ULN)
- No clinically significant abnormalities in urinalysis results
- Subjects infected with HIV are eligible if they meet all the following criteria: (a) CD4 count is ≥350 cells/uL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications (b) Probable long-term survival with HIV if cancer were not present (c) Stable on a highly active antiretroviral therapy (HAART) regimen for ≥4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study (d) HIV is not multi-drug resistant (e) Taking medication and/or receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication
- ≥18 years; Females of child-bearing potential must test negative for pregnancy at the time of screening and must agree to use a highly effective method of birth control; Male subjects must agree to use condoms
- Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting
- Initial diagnosis of metastatic disease (as per American Joint Committee on Cancer 8th Edition) ≤6 weeks prior to screening
- Subject has one or more metastatic lesions measurable by CT scan or MRI according to RECIST Version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and within 7 days prior to randomisation
- Subject has adequate biological parameters: (a) Absolute neutrophil count ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin ≥9 g/dL obtained ≤14 days prior to randomisation.
- Adequate hepatic function: (a) Serum total bilirubin ≤1.5x upper limit of normal (b) Aspartate aminotransferase and alanine aminotransferase ≤2.5x ULN
- Adequate renal function with a creatinine clearance of >30 mL/min
What rules you out
- Any other medical or social condition deemed by the investigator to be likely to interfere with a subject’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or any components of 5-FU, LV or oxaliplatin.
- Known hypersensitivity to any of the components of nab-paclitaxel or gemcitabine
- Concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease, including: (a) Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening (b) High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year prior to screening (c) New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure (d) Known historical or active infection with hepatitis B, or active infection with hepatitis C
- Active infection or an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing , which in the investigator’s opinion might compromise the subject’s participation in the study or affect the study outcome.
- Unwilling or unable to comply with study procedures and/or study visits, including long-term follow-up for survival.
- Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy: (a) Palliative radiotherapy is permitted (b) Placement of biliary stent/tube is permitted.
- Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present.
- Subject has only localised advanced disease.
- Documented serum albumin <3 g/dL within 7 days prior to randomisation
- Known history of central nervous system metastases.
- Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, diarrhoea > Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, or partial bowel obstruction.
- History of any second malignancy in the last 2 years; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Subjects with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years prior to screening. Subjects who have a concurrent malignancy that is clinically stable and does not require tumour-directed treatment are eligible.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.