Phase 2 Pancreatic Cancer Trial, Recruiting NCT05821556 Sponsor: National Cancer Institute, Naples Condition: Pancreatic Cancer
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Phase 2 Pancreatic Cancer Trial, Recruiting

NCT05821556
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have given written consent to take part in the study and its related tests.
  • People who have been diagnosed with pancreatic cancer (PDAC) that has spread to other parts of the body, confirmed by a tissue or cell sample.
  • People who have not yet received any treatment (chemotherapy, radiation, or surgery) for their pancreatic cancer.
  • People of any sex aged 18 or older.
  • People who are generally well enough to carry out light activity and care for themselves (a doctor will assess this using a standard scale called ECOG, with a score of 0 or 1 required).
  • People whose cancer can be measured on imaging scans, according to standard criteria called RECIST 1.1.
  • People enrolled in the PAXG treatment group must have had a specific enzyme called DPD already tested and documented.
  • People whose blood counts are within acceptable ranges — including white blood cells, platelets, and haemoglobin (a doctor will check these).
  • People whose liver function blood tests are within acceptable ranges (a doctor will check these).
  • People whose kidney function is within acceptable ranges, based on blood tests or a calculated kidney function score (a doctor will check this).

Who may not be able to join:

  • People who have had another cancer diagnosed within the past year, with exceptions for certain treated skin cancers or cervical pre-cancer.
  • People who have already received chemotherapy or other medical treatments for their metastatic pancreatic cancer (previous chemotherapy after surgery may be acceptable if it ended more than 6 months ago — confirm with trial site).
  • People who have previously been treated with a type of drug called an HDAC inhibitor, or with medications that work in a similar way, such as valproic acid (an epilepsy and mood medication).
  • People who have used statins, fibrates, or any cholesterol-lowering medication at any point in the 3 months before joining the study.
  • People with a known allergic reaction to statins or to any other medications used in this trial.
  • People who have had major surgery within 4 weeks before enrolling.
  • People who are pregnant or breastfeeding.
  • People whose cancer has spread to the brain.
  • People with hepatitis or any serious liver condition.
  • People with severe or poorly controlled illness, or any other condition that the trial doctor considers would make participation unsafe or interfere with the study.
  • People with a heart condition called long QT syndrome, or whose heart rhythm measurement (QTc interval) is above a certain level, or who are taking medications that affect heart rhythm (confirm with trial site for the specific medication list).
  • People with a history of difficulty cooperating with medical treatment, or any condition that may affect their ability to understand and consent to the study.
  • People who have participated in another clinical drug or medical device trial within 30 days before the start of treatment.
  • People who are unable to swallow oral (tablet/capsule) medications, who require feeding through a vein, who have had surgery that affects how the gut absorbs food or medicine, or who have an active stomach ulcer.
  • People who are sexually active and of childbearing potential but are unwilling to use contraception during the study and for 6 months after the last treatment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Alfredo Budillon, IRCCS I.N.T. "G. Pascale

Phone: 08117770357

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
National Cancer Institute, Naples
Registry
ClinicalTrials.gov
Start date
12 June 2023
Est. completion
1 August 2026

Where this trial is recruiting

🇮🇹 Italy 🇪🇸 Spain

Primary endpoints

Progression Free Survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov