Recruiting nowEarly phase 1
| Registry number | NCT07627191 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Early phase 1 |
| Design | not randomised, open label |
| Taking part | 30 people (planned) |
| Who can join | aged 18 Years to 99 Years |
| Run by | University of Arizona |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug GLP1-RA (semaglutide)
What it is measuring
Incidence of Treatment Emergent Adverse Events [Safety] attributed to GLP1-RA and/or its interaction with chemotherapy
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Early phase 1. The earliest human testing. The question is how the drug behaves in the body, not yet whether it helps.
How the researchers describe it
There is a growing number of patients diagnosed with gastrointestinal cancers who are also simultaneously being treated with GLP-1 Receptor Agonists (RA)s. To date, no clinical trial data exists to establish safety and/or feasibility with use of GLP-1 RAs during chemotherapy in the metastatic setting. The goal of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and correlative analyses of combining GLP-1 RAs with standard chemotherapy in patients with metastatic pancreatic, colorectal, or hepatocellular cancers in the first-line setting.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Histological or cytological diagnosis of pancreatic adenocarcinoma or colorectal adenocarcinoma. Previous tumor tissue testing is acceptable. Please refer to the "additional HCC cohort criteria" below.
- The subject has disease that is not amenable to curative-intent management (e.g., oligometastatic disease)
- Measurable disease per RECIST v1.1 as determined by the investigator
- Patients must be appropriate candidates for first-line, SOC treatment.
- SOC treatment as defined by NCCN® guidelines or institutional standard is allowable, however, options restricted to:
- Colorectal: FOLFOX or FOLIFIRI +/- bevacizumab
- Pancreatic: mFOLFIRINOX
- HCC: Tremelimumab/Durvalumab
- Patients are eligible who received prior perioperative chemotherapy for curative intent treatment and recurred ≥ 6 months since last dose of chemotherapy.
- ≥ 18 years old on day of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate archival frozen or fixed tissue available from primary or metastatic site for genotypic analysis (at least 15 unstained slides and/or tumor block)
- Adequate hematologic and organ function laboratory values as follows:
- The ANC ≥ 1500/mm3 without colony stimulating factor support;
- Platelets ≥ 75,000/mm3;
- Hemoglobin ≥ 9 g/dL;
- Bilirubin ≤ 1.5 ´ the ULN.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07627191, registered by University of Arizona on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.