Study of Effect of Azeliragon in Patients Refractory to First-Line Metastatic Pancreatic Cancer

Metastatic Pancreatic Cancer Clinical Trial

Official title:

A Phase I/II Open Label Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients Refractory to First-Line Treatment of Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766748
• Other study ID #: CAN-201 MPC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2023
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: Cantex Pharmaceuticals
• Contact: Stephen Marcus, MD
• Phone: 954-315-3660
• Email: smarcus[@]cantex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open label study to determine the safety and preliminary evidence of a therapeutic effect of azeliragon in patients refractory to first-line or second-line treatment of metastatic pancreatic cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient must have histologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas for which potential curative measures, such as resection of an isolated metastasis, are not available.

2. Patient should have previously been treated with a Gemcitabine/Abraxane or FOLFIRINOX- based regimen.

3. Toxicity from prior chemotherapy other than alopecia has recovered to Grade = 1 (CTCAE 1.0) or are at baseline (such as stable G2 neuropathy).

4. Male or non-pregnant and non-lactating female and = 18 to = 80 years of age.

5. Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained = 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) = 1.0 × 109/L; Platelet count = 75,000/mm3 (75 × 109/L); Hemoglobin (Hgb) = 9 g/dL without transfusion or growth factor support

6. Patient has the following blood chemistry levels at Screening (obtained = 14 days

prior to enrollment) and at Baseline-Day 0:

• AST (SGOT), ALT (SGPT) = 2.5 × upper limit of normal range (ULN), unless liver metastases are present, then = 5 x ULN is acceptable. Total bilirubin = 1.5 × ULN.
• Estimated creatinine clearance of > 60 mL/min (per Cockroft-Gault formula)

7. Patient has ECOG performance status of = 2

8. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study-related activities.

Exclusion Criteria:

1. Patient has a life expectancy, per investigator assessment, of less than 3 months.

2. Patient has experienced an increase of ECOG to > 2 between Screening and the time of first dose with study drug.

3. Patient has active, uncontrolled bacterial, or fungal infection(s) requiring systemic therapy.

4. Patients receiving CYP 2C8 inhibitors noted in Section 5.3 of the protocol.

5. Patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity.

6. Patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication.

7. Patients with a gastrointestinal condition that could interfere with swallowing or absorption.

8. Females of childbearing potential who are sexually active or males with female partners of childbearing potential, where either the female or the male is unwilling to use a highly effective method of contraception during the trial and for 6 months after the last administration of study drug.

9. Patients with concurrent participation in another interventional clinical trial or use of another investigational agent within 14 days of starting study drug. Patients who are participating in non-interventional clinical trials (e.g., quality of life, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Azeliragon
Azeliragon is an orally administered inhibitor of Receptor for Advanced Glycation Endproducts (RAGE) which is formulated as a 5mg hard gelatin capsule.

Locations

Country	Name	City	State
United States	Boca Raton Regional Hospital, Lynn Cancer Institute	Boca Raton	Florida
United States	Williamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Prisma Health - Upstate	Greenville	South Carolina
United States	Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California
United States	AHN Cancer Institute - Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Texas Oncology - Northeast Texas	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cantex Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended Phase 2 Dose	Assessment of the recommended phase 2 dose (RP2D) of azeliragon in patients with metastatic pancreatic cancer.	8 weeks
Secondary	AE and SAE Frequency	The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.	8 weeks
Secondary	Pain after treatment initiation	Pain as determined by Brief Pain Assessment at 2, 4, 6 and 8 weeks after initiation of treatment.	8 weeks
Secondary	Average daily opioid consumption.	Change in average daily total opioid consumption (in mg of morphine equivalent doses) at Weeks 2, 4, 6, and 8.	8 weeks
Secondary	Plasma CA19-9 levels	Change in plasma CA19-9 levels.	8 weeks
Secondary	Disease Control	Disease control as indicated by Complete Response + Partial Response + Stable Disease at 2 months and longer as determined by RECIST criteria, provided CT or MRI scans were performed consistent with standard of care.	8 weeks
Secondary	Overall survival	Measurement of time from first dose of azeliragon until death from any cause.	8 weeks
Secondary	Change in Eastern Cooperative Oncology Group (ECOG) status.	Measurement of change in grading of patient status based on descriptions in the ECOG performance status scale. Grading scale has a minimum value of 0 and maximum value of 5, with 0 being the best outcome and 5 being the worst.	8 weeks
Secondary	Serum albumin	Change from baseline in serum albumin concentration.	8 weeks
Secondary	Body Weight	Change from baseline in body weight.	8 weeks