Metastatic Pancreatic CancerPhase 1/2NCT05766748
Study of Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer
A Phase 1/2 study testing Azeliragon in people with Metastatic Pancreatic Cancer, run by Cantex Pharmaceuticals at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Azeliragon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jun 2023to May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient should have previously been treated with a Gemcitabine/Abraxane or FOLFIRINOX- based regimen.
- Toxicity from prior chemotherapy other than alopecia has recovered to Grade ≤ 1 (CTCAE 1.0) or are at baseline (such as stable G2 neuropathy).
- Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
- 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
- Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0:
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- 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)
- Patient has ECOG performance status of ≤ 2
- 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.
Who cannot join
- Patient has a life expectancy, per investigator assessment, of less than 3 months.
- Patient has experienced an increase of ECOG to > 2 between Screening and the time of first dose with study drug.
- Patient has active, uncontrolled bacterial, or fungal infection(s) requiring systemic therapy.
- Patients receiving CYP 2C8 inhibitors noted in Section 5.3 of the protocol.
- 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.
- Patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication.
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- Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
- 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.
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, 33486
Warren Brenner, MD, 561-955-6400, wbrenner@baptisthealth.net
- Recruiting
Williamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Marc Uemura, MD, 541-683-5001, marc.uemura@usoncology.com
- Recruiting
Prisma Health - Upstate
Greenville, South Carolina, 29605
Ki Chung, MD, 864-455-3600, ki.chung@prismahealth.org
- Recruiting
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Andrew Hendifar, MD, 310-423-2217, andrew.hendifar@cshs.org
- Recruiting
AHN Cancer Institute - Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Nathan Bahary, MD, 412-359-6391, nathan.bahary@ahn.org
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Donald Richards, MD, 903-579-9800, donald.richards@usoncology.com
About this study
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
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
- Being tested
- Azeliragon
- Keywords
- azeliragon
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzeliragonDrug
Also called TTP488
Azeliragon is an orally administered inhibitor of Receptor for Advanced Glycation Endproducts (RAGE) which is formulated as a 5mg hard gelatin capsule.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Azeliragon will be orally administered to 5 groups of 6 subjects, with escalation of dosing occurring with each subsequent group.
Dose Level 1 is a loading dose of 15mg once daily for 6 days, followed by a dose of 5mg once daily for the rest of the study.
Dose Level 2 is a loading dose of 15mg twice daily for 6 days, followed by a dose of 10mg once daily for the rest of the study.
Dose Level 3 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 20mg once daily for the rest of the study.
Dose Level 4 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 15mg twice daily for the rest of the study.
Dose Level 5 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 25mg twice daily for the rest of the study.
Escalation will continue until stopping rules are met or the highest defined dose level is reached. The trial will be closed to accrual if the first dose level is deemed intolerable. Receives: Drug: Azeliragon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose
Assessment of the recommended phase 2 dose (RP2D) of azeliragon in patients with metastatic pancreatic cancer.
Measured: 8 weeks
Secondary outcomes (9)
AE and SAE Frequency
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
Measured: 8 weeks
Pain after treatment initiation
Pain as determined by Brief Pain Assessment at 2, 4, 6 and 8 weeks after initiation of treatment.
Measured: 8 weeks
Average daily opioid consumption.
Change in average daily total opioid consumption (in mg of morphine equivalent doses) at Weeks 2, 4, 6, and 8.
Measured: 8 weeks
Plasma CA19-9 levels
Change in plasma CA19-9 levels.
Measured: 8 weeks
Disease Control
Disease control as indicated by Complete Response + Partial Response + Stable Disease at 2 months and longer as determined by RECIST criteria, provided CT or MRI scans were performed consistent with standard of care.
Measured: 8 weeks
Overall survival
Measurement of time from first dose of azeliragon until death from any cause.
Measured: 8 weeks
Change in Eastern Cooperative Oncology Group (ECOG) status.
Measurement of change in grading of patient status based on descriptions in the ECOG performance status scale. Grading scale has a minimum value of 0 and maximum value of 5, with 0 being the best outcome and 5 being the worst.
Measured: 8 weeks
Serum albumin
Change from baseline in serum albumin concentration.
Measured: 8 weeks
Body Weight
Change from baseline in body weight.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Jun 2023
- Primary completionFeb 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Hendifar, MD, Principal investigator, Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766748
- Sponsor's protocol ID
- CAN-201 MPC
- Status last verified
- Jun 2024
- First submitted
- 24 Feb 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05766748
- Acronym / sponsor ID
- CAN-201 MPC
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- azeliragon
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cantex PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: AzeliragonAzeliragon will be orally administered to 5 groups of 6 subjects, with escalation of dosing occurring with each subsequent group. Dose Level 1 is a loading dose of 15mg once daily for 6 days, followed by a dose of 5mg once daily for the rest of the study. Dose Level 2 is a loading dose of 15mg twice daily for 6 days, followed by a dose of 10mg once daily for the rest of the study. Dose Level 3 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 20mg once daily for the rest of the study. Dose Level 4 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 15mg twice daily for the rest of the study. Dose Level 5 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 25mg twice daily for the rest of the study. Escalation will continue until stopping rules are met or the highest defined dose level is reached. The trial will be closed to accrual if the first dose level is deemed intolerable. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Patient should have previously been treated with a Gemcitabine/Abraxane or FOLFIRINOX- based regimen.
- Toxicity from prior chemotherapy other than alopecia has recovered to Grade ≤ 1 (CTCAE 1.0) or are at baseline (such as stable G2 neuropathy).
- Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
- 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
Key exclusion criteria (9 listed)
- Patient has a life expectancy, per investigator assessment, of less than 3 months.
- Patient has experienced an increase of ECOG to > 2 between Screening and the time of first dose with study drug.
- Patient has active, uncontrolled bacterial, or fungal infection(s) requiring systemic therapy.
- Patients receiving CYP 2C8 inhibitors noted in Section 5.3 of the protocol.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzeliragonAlso: TTP488Azeliragon is an orally administered inhibitor of Receptor for Advanced Glycation Endproducts (RAGE) which is formulated as a 5mg hard gelatin capsule. | Drug | Treatment Group |
Primary outcome
Recommended Phase 2 Dose
Time frame: 8 weeks
Assessment of the recommended phase 2 dose (RP2D) of azeliragon in patients with metastatic pancreatic cancer.
9 secondary outcomes
AE and SAE Frequency
Time frame: 8 weeks
Pain after treatment initiation
Time frame: 8 weeks
Average daily opioid consumption.
Time frame: 8 weeks
Plasma CA19-9 levels
Time frame: 8 weeks
Disease Control
Time frame: 8 weeks
Overall survival
Time frame: 8 weeks
Change in Eastern Cooperative Oncology Group (ECOG) status.
Time frame: 8 weeks
Serum albumin
Time frame: 8 weeks
Body Weight
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Hendifar, MD principal investigator
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Azeliragon in people with Metastatic Pancreatic Cancer, run by Cantex Pharmaceuticals at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Marcus, MD (954-315-3660, smarcus@cantex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.