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Topoisomerase I inhibitor
Liposomal Irinotecan for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Kian-Huat Lim, M.D, Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 30 days after completion of paricalcitol treatment (estimated to be 28 weeks)
Awards & highlights
Study Summary
This trial will study the effectiveness of a combination of drugs to treat pancreatic cancer in patients who have already tried and failed one treatment.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 30 days after completion of paricalcitol treatment (estimated to be 28 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 30 days after completion of paricalcitol treatment (estimated to be 28 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tolerability between two different dose levels of paricalcitol added to the combo regimen of liposomal irinotecan plus 5-FU / LV as measured by the occurrence of grade 3 and 4 toxicities
Secondary outcome measures
CA19-9 biochemical response rate
Duration of complete response
Duration of overall response
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group 2: Paricalcitol 7 mcg/kg Days 1 and 8Experimental Treatment6 Interventions
5-FU, LV, and nal-IRI will be administered at standard fixed doses. Briefly, 5-FU will be given at a dose of 2400 mg/m^2 continuous IV infusion over 46 hours, LV will be given at 400 mg/m^2 IV over 30 minutes, and liposomal irinotecan will be given at a dose of 70 mg/m^2 IV over 90 minutes (unless homozygous for the UGT1A1*28 7/7 allele, in which case the dose will start at 50 mg/m^2 and escalate to 70 mg/m^2 in subsequent cycles if no excessive toxicity is experienced) on Day 1 of each 14-day cycle.
Paricalcitol 7 mcg/kg on Days 1 and 8
Treatment with liposomal irinotecan plus 5FU/ LV may continue indefinitely, and treatment with paricalcitol may continue for up to 10 cycles (20 weeks)
Group II: Group 1: Paricalcitol 75 mcg Days 1 and 8Experimental Treatment6 Interventions
5-FU, LV, and nal-IRI will be administered at standard fixed doses. Briefly, 5-FU will be given at a dose of 2400 mg/m^2 continuous IV infusion over 46 hours, LV will be given at 400 mg/m^2 IV over 30 minutes, and liposomal irinotecan will be given at a dose of 70 mg/m^2 IV over 90 minutes (unless homozygous for the UGT1A1*28 7/7 allele, in which case the dose will start at 50 mg/m^2 and escalate to 70 mg/m^2 in subsequent cycles if no excessive toxicity is experienced) on Day 1 of each 14-day cycle.
Paricalcitol 75 mcg on Days 1 and 8
Treatment with liposomal irinotecan plus 5FU/ LV may continue indefinitely, and treatment with paricalcitol may continue for up to 10 cycles (20 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
FDA approved
Irinotecan
FDA approved
Leucovorin
FDA approved
Fluorouracil
FDA approved
Tumor biopsy
2014
Completed Phase 2
~240
Serum and plasma blood samples
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,208 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,853 Total Patients Enrolled
Kian-Huat Lim, M.D, Ph.D.Principal InvestigatorWashington University School of Medicine
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