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New treatment option for Small Bowel Adenocarcinoma
Official title Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors
ClinicalTrials.gov ID: NCT06835387
What this study is testing
What is Nanoliposomal irinotecan?
Nanoliposomal irinotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small bowel adenocarcinoma.
Also referred to as Onivyde.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study regimen will be administered on an outpatient basis and all medications are administered intravenously (IV). Subjects will receive treatment on Day 1 and Day 15 of each 28-day cycle consisting of the following: nanoliposomal irinotecan at 50 mg/m2, followed by oxaliplatin 60 mg/m2, followed by leucovorin at 400 mg/m2 30 minutes after completion of oxaliplatin, followed by 5-FU 2400 mg/m2 60 minutes after leucovorin completion.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject has been informed about the nature of the study, and has agreed to participate in the study, and signed the ICF prior to participation in any...
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤ 1 within 28 days prior to registration.
- Histological or cytologically confirmed small bowel adenocarcinoma per AJCC staging manual, 8th edition that has not been previously treated in the...
- Mismatch repair proficient (MMRp) and/or microsatellite stable (MSS) disease per institutional standard of care testing.
You likely can't join if
- Adenocarcinoma originating in the ampulla or appendix (duodenal tumors that involve the ampulla but originate in the duodenum are eligible).
- Neuroendocrine or any other histology different than adenocarcinoma.
- Prior treatment with irinotecan.
- Prior treatment of small bowel adenocarcinoma (SBA) in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy:
- Palliative radiotherapy is permitted but lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered...
- Placement of biliary stent/tube is permitted.
See the full eligibility criteria
Who can join
- Subject has been informed about the nature of the study, and has agreed to participate in the study, and signed the ICF prior to participation in any study-related activities. Also, as determined by the enrolling...
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤ 1 within 28 days prior to registration.
- Histological or cytologically confirmed small bowel adenocarcinoma per AJCC staging manual, 8th edition that has not been previously treated in the metastatic setting. people treated in the adjuvant setting who...
- Mismatch repair proficient (MMRp) and/or microsatellite stable (MSS) disease per institutional standard of care testing.
- Subject has one or more metastatic lesion(s) measurable by CT scan (or MRI, if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria. Lesions in a prior radiation field must have...
- Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.
- Platelets (Plt) ≥ 100,000 cells/mm3
- Absolute Neutrophil Count (ANC) ≥ 1,500 cells/mm3; without the use of hemopoietic growth factors
- Hemoglobin (Hgb) ≥ 9 g/dL
- Calculated creatinine clearance ≥ 30 mL/min; Cockcroft-Gault formula for actual body weight should be used for calculation. For people with a body mass index (BMI) \> 30 kg/m2, adjusted body weight should be used instead
- Total bilirubin ≤ 1.5 × ULN
- Aspartate aminotransferase (AST) ≤ 2 × ULN; \< 5× with liver metastases
- Alanine aminotransferase (ALT) ≤ 2 × ULN; \< 5× with liver metastases
- Albumin ≥ 2.5 gm/dL
- PT/INR and aPTT ≤ 1.5 x ULN; people on warfarin or other vitamin K antagonists should be discussed with the sponsor-investigator.
- Urinalysis: Urinalysis results without clinically significant abnormalities, per the investigator's assessment
- Electrocardiogram (ECG) without any clinically significant findings (QT interval corrected by Fridericia's formula (QTcF) ≤450 msec and no known arrhythmias) and per the investigator's assessment.
- Females of childbearing potential must have a negative urine or serum pregnancy test within ≤ 7 days prior to registration. If a urine test is done and it is positive or cannot be confirmed as negative, a serum...
- Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception. Males able to...
- people with known human immunodeficiency virus (HIV) are eligible if they meet all the following criteria:
- CD4 count is ≥350 cells/uL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications;
- Probable long-term survival with HIV if cancer were not present;
- 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...
- HIV is not multi-drug resistant;
- Taking medication and/or receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication. NOTE: Testing for HIV is not required at screening unless mandated by local...
- people with known chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. people with a history of hepatitis C virus (HCV) infection must have been...
What rules you out
- Adenocarcinoma originating in the ampulla or appendix (duodenal tumors that involve the ampulla but originate in the duodenum are eligible).
- Neuroendocrine or any other histology different than adenocarcinoma.
- Prior treatment with irinotecan.
- Prior treatment of small bowel adenocarcinoma (SBA) in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy:
- Palliative radiotherapy is permitted but lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.
- Placement of biliary stent/tube is permitted.
- Palliative surgery (for example to treat obstruction)
- Known history of central nervous system (CNS) metastases. (people on a stable or decreasing dose of steroids and deemed clinically stable as per the investigator's assessment are eligible).
- Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, diarrhea \> Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, or bowel...
- Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
- people with an active malignancy in the last 2 years. The following people may be eligible: people with prior history of in-situ cancer or basal or squamous cell skin cancer. people with a history of other malignancies...
- Known hypersensitivity to any of the components of nanoliposomal irinotecan, other liposomal products, or any components of 5-FU, LV or oxaliplatin.
- Concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease, including:
- Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before registration
- High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year prior to registration
- New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
- Active infection or an unexplained fever \>38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, people with tumor fever may be enrolled), which in the...
- Major surgery, other than diagnostic surgery, within 4 weeks prior to registration.
- Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. people are ineligible if:
- they are unable to discontinue the use of strong inhibitors of CYP3A, CYP2C8 and UGT1A1 at least 1 week prior to registration;
- they are unable to discontinue the use of strong CYP3A and CYP2C8 inducers at least 2 weeks prior to registration;
- There is presence of any contraindications outlined in the Contraindications or Warnings and Precautions sections of the IB for nanoliposomal irinotecan, or in the prescribing information for 5-FU, LV or oxaliplatin.
- people who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
- History of systemic connective tissue disorders (e.g. lupus, scleroderma, arteritis nodosa).
- people who have received a live vaccine within 4 weeks prior to registration.
- History of the following: interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple...
- Known low or absent dihydropyridine dehydrogenase (DPD) or UGT1A1activity. Testing for DPD or UGT1A1 deficiency is not mandatory but where required by local regulations, testing must be performed using a validated...
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Fort Wayne, Indiana, United States
- St Louis, Missouri, United States
- Morristown, New Jersey, United States
- Dallas, Texas, United States
- Richmond, Virginia, United States
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Chicago, Illinois, United States; Fort Wayne, Indiana, United States; St Louis, Missouri, United States; Morristown, New Jersey, United States; Dallas, Texas, United States and 1 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.