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

Trial ID: NCT05766748

Interventional - Phase 1/2 - Unknown status

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

Interventions

• Azeliragon

Eligibility

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.

Sponsor

Cantex Pharmaceuticals

Source: ClinicalTrials.gov

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