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

NCT ID: NCT05766748

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

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.

Group Type: EXPERIMENTAL

Azeliragon

Intervention Type: DRUG

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

Interventions

Azeliragon

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

Intervention Type: DRUG

Other Intervention Names

TTP488

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantex Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Hendifar, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Locations

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

Site Status: RECRUITING

Boca Raton Regional Hospital, Lynn Cancer Institute

Boca Raton, Florida, United States

Site Status: RECRUITING

Williamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Site Status: RECRUITING

AHN Cancer Institute - Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Prisma Health - Upstate

Greenville, South Carolina, United States

Site Status: RECRUITING

Texas Oncology - Northeast Texas

Tyler, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen Marcus, MD

Role: CONTACT

smarcus@cantex.com

954-315-3660

Facility Contacts

Andrew Hendifar, MD

Role: primary

andrew.hendifar@cshs.org

310-423-2217

Warren Brenner, MD

Role: primary

wbrenner@baptisthealth.net

561-955-6400

Marc Uemura, MD

Role: primary

marc.uemura@usoncology.com

541-683-5001

Nathan Bahary, MD

Role: primary

nathan.bahary@ahn.org

412-359-6391

Ki Chung, MD

Role: primary

ki.chung@prismahealth.org

864-455-3600

Donald Richards, MD

Role: primary

donald.richards@usoncology.com

903-579-9800

Other Identifiers

CAN-201 MPC

Identifier Type: -

Identifier Source: org_study_id