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Azeliragon for Refractory Pancreatic Cancer

Phase 1 & 2
Recruiting
Led By Andrew Hendifar, MD
Research Sponsored by Cantex Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient should have previously been treated with a Gemcitabine/Abraxane or FOLFIRINOX-based regimen.
Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial tests a new drug to treat pancreatic cancer that has not been helped by other treatments.

Who is the study for?
This trial is for adults aged 18-80 with advanced or metastatic pancreatic cancer that can't be cured by surgery. They must have tried Gemcitabine/Abraxane or FOLFIRINOX treatments and recovered from previous chemo effects, except hair loss. Participants need normal blood counts and organ function, not be pregnant or breastfeeding, willing to use contraception, and able to swallow pills.Check my eligibility
What is being tested?
The study tests Azeliragon's safety and potential effectiveness in patients whose metastatic pancreatic cancer didn't respond to first-line or second-line treatments. It's an open-label trial where everyone knows they're getting the drug; there’s no placebo group.See study design
What are the potential side effects?
Specific side effects of Azeliragon aren’t listed here but generally could include typical reactions like nausea, fatigue, allergic responses, liver issues (as it affects enzyme levels), changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with Gemcitabine/Abraxane or FOLFIRINOX.
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I am a man or a woman not pregnant or breastfeeding, aged 18 to 80.
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My pancreatic cancer is advanced and cannot be cured with surgery.
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I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended Phase 2 Dose
Secondary outcome measures
AE and SAE Frequency
Average daily opioid consumption.
Body Weight
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Azeliragon will be orally administered to 3 groups of 6 subjects, with escalation of dosing occurring with each subsequent group. Dose Level 1 consists of a loading dose of 15mg once daily for 6 days, followed by a continuous dose of 5mg once daily for the remainder of the study. Dose Level 2 consists of a loading dose of 15mg twice daily for 6 days, followed by a continuous dose of 10mg once daily for the remainder of the study. Dose Level 3 consists of a loading dose of 30mg twice daily for 6 days, followed by a continuous dose of 20mg once daily for the remainder of the study. Escalation will continue until stopping rules are met or the highest defined dose level is reached. The trial will be closed to accrual if the first dose level is deemed intolerable.

Find a Location

Who is running the clinical trial?

Cantex PharmaceuticalsLead Sponsor
12 Previous Clinical Trials
348 Total Patients Enrolled
Andrew Hendifar, MDPrincipal InvestigatorCedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
4 Previous Clinical Trials
126 Total Patients Enrolled

Media Library

Azeliragon (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05766748 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass those aged 25 and above?

"This research endeavour is searching for participants aged 18-80."

Answered by AI

What is the current enrollment size for this clinical exploration?

"The need for 18 participants, meeting the established inclusion criteria, is necessary to commence this study. Patients are able to join from multiple locations including Boca Raton Regional Hospital, Lynn Cancer Institute in Boca Raton, Florida and Williamette Valley Cancer Institute and Research Center in Eugene, Oregon."

Answered by AI

Are recruitment efforts for this research endeavor ongoing?

"Clinicaltrials.gov confirms that this clinical trial is actively seeking participants - the study was first posted on June 1st 2023, and its details have been most recently revised on June 2nd 2023."

Answered by AI

How many locations have embraced this clinical experiment?

"Boca Raton Regional Hospital, Lynn Cancer Institute in Boca Raton, Florida, Williamette Valley Cancer Institute and Research Center in Eugene, Oregon, AHN Cancer Institute - Allegheny General Hospital in Pittsburgh Pennsylvania are all recruiting patients for this trial. Additionally 6 additional medical sites across the USA are also enrolling participants."

Answered by AI

Are there any opportunities to join this research endeavor?

"This clinical trial is searching for 18 patients with pancreatic cancer who are between the ages of eighteen and eighty."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Effect of Azeliragon in Patients Refractory to First-Line Metastatic Pancreatic Cancer
2023. "Study of Effect of Azeliragon in Patients Refractory to First-Line Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766748.
~6 spots leftby Oct 2024
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