RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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 Prior Treatment of Metastatic Pancreatic Cancer

Quick Facts

Study Start:2023-06-01

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05766748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Stephen Marcus, MD

CONTACT

954-315-3660

smarcus@cantex.com

Principal Investigator

Andrew Hendifar, MD

PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Study Locations (Sites)

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048

United States

Boca Raton Regional Hospital, Lynn Cancer Institute

Boca Raton, Florida, 33486

United States

Williamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401

United States

AHN Cancer Institute - Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

Prisma Health - Upstate

Greenville, South Carolina, 29605

United States

Texas Oncology - Northeast Texas

Tyler, Texas, 75702

United States

Collaborators and Investigators

Sponsor: Cantex Pharmaceuticals

Andrew Hendifar, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01

Study Completion Date2025-05

Study Record Updates

Study Start Date2023-06-01

Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

azeliragon

Additional Relevant MeSH Terms

Metastatic Pancreatic Cancer