Clinical trial NCT05766748: Study of 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Metastatic Pancreatic Cancer
Keywords: azeliragon
Lead sponsor: Cantex Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recommended Phase 2 Dose
timeFrame: 8 weeks
Secondary outcomes:
measure: AE and SAE Frequency
timeFrame: 8 weeks
measure: Pain after treatment initiation
timeFrame: 8 weeks
measure: Average daily opioid consumption.
timeFrame: 8 weeks
measure: Plasma CA19-9 levels
timeFrame: 8 weeks
measure: Disease Control
timeFrame: 8 weeks
measure: Overall survival
timeFrame: 8 weeks
measure: Change in Eastern Cooperative Oncology Group (ECOG) status.
timeFrame: 8 weeks
measure: Serum albumin
timeFrame: 8 weeks
measure: Body Weight
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital, Lynn Cancer Institute
state: Florida
city: Eugene
country: United States
facility: Williamette Valley Cancer Institute and Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: AHN Cancer Institute - Allegheny General Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas
state: Texas
Study officials:
affiliation: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
name: Andrew Hendifar, MD
role: PRINCIPAL_INVESTIGATOR
References: