Study of Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer

NCT05766748 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CAN-201 MPC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Metastatic Pancreatic Cancer

Keywords

azeliragon

Outcome Measures

Primary Outcomes (1)

• Recommended Phase 2 Dose

  Assessment of the recommended phase 2 dose (RP2D) of azeliragon in patients with metastatic pancreatic cancer.

  8 weeks

Secondary Outcomes (9)

• AE and SAE Frequency

  8 weeks

• Pain after treatment initiation

  8 weeks

• Average daily opioid consumption.

  8 weeks

• Plasma CA19-9 levels

  8 weeks

• Disease Control

  8 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

Azeliragon will be orally administered to 5 groups of 6 subjects, with escalation of dosing occurring with each subsequent group. Dose Level 1 is a loading dose of 15mg once daily for 6 days, followed by a dose of 5mg once daily for the rest of the study. Dose Level 2 is a loading dose of 15mg twice daily for 6 days, followed by a dose of 10mg once daily for the rest of the study. Dose Level 3 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 20mg once daily for the rest of the study. Dose Level 4 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 15mg twice daily for the rest of the study. Dose Level 5 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 25mg twice daily for the rest 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.

Drug: Azeliragon

Interventions

Azeliragon DRUG

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

Also known as: TTP488

Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient should have previously been treated with a Gemcitabine/Abraxane or FOLFIRINOX- based regimen.
• Toxicity from prior chemotherapy other than alopecia has recovered to Grade ≤ 1 (CTCAE 1.0) or are at baseline (such as stable G2 neuropathy).
• Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
• 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
• 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)
• Patient has ECOG performance status of ≤ 2
• 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.

You may not qualify if:

• Patient has a life expectancy, per investigator assessment, of less than 3 months.
• Patient has experienced an increase of ECOG to \> 2 between Screening and the time of first dose with study drug.
• Patient has active, uncontrolled bacterial, or fungal infection(s) requiring systemic therapy.
• Patients receiving CYP 2C8 inhibitors noted in Section 5.3 of the protocol.
• 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.
• Patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication.
• Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
• 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.
• 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.

Sponsors & Collaborators

• Cantex Pharmaceuticals: lead

Study Sites (6)

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States

RECRUITING

Boca Raton Regional Hospital, Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

RECRUITING

Williamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

RECRUITING

AHN Cancer Institute - Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Prisma Health - Upstate

Greenville, South Carolina, 29605, United States

RECRUITING

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

azeliragon

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Andrew Hendifar, MD

  Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Marcus, MD

CONTACT

954-315-3660; smarcus@cantex.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 13, 2023
• Study Start: June 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

US (6)