NALIRIFOX for Small Bowel Cancer

Recruiting in Palo Alto (17 mi)

Overseen byTiago Biachi de Castria, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Tiago Biachi de Castria

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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. Subjects will receive up to 6 cycles of NALIRIFOX then based on response and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue. Subjects will continue de-escalated maintenance treatment until progression per RECIST 1.1, intolerable toxicity or physician/subject choice to discontinue.

Eligibility Criteria

This trial is for adults with advanced small bowel cancer that can't be surgically removed. Participants must have measurable disease, adequate organ function, and no prior chemotherapy for metastatic disease. They cannot join if they've had recent surgery or radiation, significant heart disease, another active cancer, or known allergies to the drugs being tested.

Inclusion Criteria

I am 18 years old or older.

Subjects infected with HIV must meet specific criteria.

Electrocardiogram (ECG) without any clinically significant findings.

+9 more

Exclusion Criteria

My cancer started in the ampulla or appendix.

Pregnant or breastfeeding.

I have a serious stomach or intestine condition.

+15 more

Participant Groups

The study tests a combination of four IV drugs (NALIRIFOX): nanoliposomal irinotecan, oxaliplatin, leucovorin, and 5-FU given every two weeks in a 28-day cycle. After six cycles of full treatment, patients may receive maintenance therapy without oxaliplatin if their doctor agrees.

1Treatment groups

Experimental Treatment

Group I: NALIRIFOX and De-escalated maintenanceExperimental Treatment4 Interventions

Cycle 1 to Cycle 6: NALIRIFOX 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. Patients will receive up to 6 cycles of NALIRIFOX. Cycle 7+: De-escalated Maintenance: Based on response to Cycles 1-6 and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue as de-escalated maintenance treatment until progression per RECIST 1.1, intolerable toxicity or physician/subject choice to discontinue.