Trial Title:
Study of Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer
NCT ID:
NCT05766748
Condition:
Metastatic Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
azeliragon
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azeliragon
Description:
Azeliragon is an orally administered inhibitor of Receptor for Advanced Glycation
Endproducts (RAGE) which is formulated as a 5mg hard gelatin capsule.
Arm group label:
Treatment Group
Other name:
TTP488
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Hendifar, MD
Phone:
310-423-2217
Email:
andrew.hendifar@cshs.org
Facility:
Name:
Boca Raton Regional Hospital, Lynn Cancer Institute
Address:
City:
Boca Raton
Zip:
33486
Country:
United States
Status:
Recruiting
Contact:
Last name:
Warren Brenner, MD
Phone:
561-955-6400
Email:
wbrenner@baptisthealth.net
Facility:
Name:
Williamette Valley Cancer Institute and Research Center
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marc Uemura, MD
Phone:
541-683-5001
Email:
marc.uemura@usoncology.com
Facility:
Name:
AHN Cancer Institute - Allegheny General Hospital
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nathan Bahary, MD
Phone:
412-359-6391
Email:
nathan.bahary@ahn.org
Facility:
Name:
Prisma Health - Upstate
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ki Chung, MD
Phone:
864-455-3600
Email:
ki.chung@prismahealth.org
Facility:
Name:
Texas Oncology - Northeast Texas
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Donald Richards, MD
Phone:
903-579-9800
Email:
donald.richards@usoncology.com
Start date:
June 1, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Cantex Pharmaceuticals
Agency class:
Industry
Source:
Cantex Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766748
