Actively Recruiting
Study of Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer
Led by Cantex Pharmaceuticals · Updated on 2024-06-14
30
Participants Needed
6
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced or metastatic pancreatic adenocarcinoma not suitable for curative surgery
- Previously treated with Gemcitabine/Abraxane or FOLFIRINOX chemotherapy
- Recovery from prior chemotherapy toxicities to Grade 1 or baseline, except alopecia
- Male or non-pregnant, non-lactating female aged 18 to 80 years
- Adequate blood counts: ANC ≥ 1.0 x 10^9/L; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 9 g/dL without transfusion
- Liver and kidney function within specified limits: AST/ALT ≤ 2.5x ULN (or ≤ 5x ULN if liver metastases), bilirubin ≤ 1.5x ULN, creatinine clearance > 60 mL/min
- ECOG performance status of 2 or less
- Informed consent signed prior to study participation
You will not qualify if you...
- Life expectancy less than 3 months
- Increase of ECOG performance status to greater than 2 between screening and first dose
- Active, uncontrolled bacterial or fungal infections needing systemic therapy
- Use of CYP 2C8 inhibitors as specified in protocol
- Serious medical or psychiatric illness compromising safety or data integrity
- Inability or unwillingness to comply with study procedures including oral medication
- Gastrointestinal conditions affecting swallowing or absorption
- Females of childbearing potential or males with partners of childbearing potential not agreeing to effective contraception during and 6 months after study
- Participation in another interventional clinical trial or investigational agent use within 14 days before study start, except non-interventional studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Actively Recruiting
2
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, United States, 33486
Actively Recruiting
3
Williamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
Actively Recruiting
4
AHN Cancer Institute - Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
5
Prisma Health - Upstate
Greenville, South Carolina, United States, 29605
Actively Recruiting
6
Texas Oncology - Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
Research Team
S
Stephen Marcus, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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