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New combo aims to extend control of tough pancreatic cancer

NCT ID NCT05249101

Disease control Sponsor: CG Pharmaceuticals, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the experimental drug ivaltinostat to standard chemotherapy (capecitabine) can help keep metastatic pancreatic cancer from worsening. About 70 adults whose cancer did not progress on initial treatment will receive either the combination or capecitabine alone. The goal is to find the best dose and see if the combination improves how long the cancer stays controlled.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age: ≥18 years * For Phase 1b, histologically or cytologically confirmed pancreatic adenocarcinoma (locally advanced or metastatic) with at least 1 prior therapy in either the advanced or perioperative setting * For Phase 1b, measurable disease and/or non-measurable disease per RECIST v1.1 * For Phase 2, histologically or cytologically confirmed pancreatic adenocarcinoma without evidence of disease progression while receiving initial chemotherapy for metastatic disease (e.g., must have had a demonstrated CR, PR, or SD following initial chemotherapy). * For Phase 2, measurable disease and/or non-measurable or no evidence of disease assessed by baseline CT (or MRI where CT is contraindicated). RECIST v1.1 will be used to allow for assessment of disease progression due to new lesions in patients with no evidence of disease at baseline. Patients with no evidence of disease following FOLFIRINOX chemotherapy will be deemed to have radiographic disease progression if new lesions are detected. * For Phase 2, treatment with FOLFIRINOX for metastatic pancreatic adenocarcinoma at full or modified doses, for a minimum of 16 weeks, and no evidence of progression based on the radiographic imaging. * a. Randomization must occur within 6 weeks of the last dose of chemotherapy. * b. Patients who have received at least 16 weeks of FOLFIRINOX combination regimen but had non-fluoropyrimidine chemotherapeutic agents discontinued prior to 16 weeks due to toxicity are eligible if they have no radiographic evidence of disease. * For Phase 2, patients who received prior chemotherapy or prior chemoradiation for a prior cancer or as adjuvant/neoadjuvant treatment for pancreatic adenocarcinoma are eligible provided at least 12 months have elapsed between the last dose of treatment and initiation of the FOLFIRINOX chemotherapy for metastatic pancreatic adenocarcinoma. * Prior radiation therapy is allowed, provided \>14 days have elapsed since completion of radiation prior to randomization. * Adequate organ function * ECOG Performance Status 0-1 at the date of signing the informed consent. Exclusion Criteria: * For Phase 2, radiographic progression of tumor per RECIST 1.1 between start of first line FOLFIRINOX chemotherapy for metastatic pancreatic adenocarcinoma and randomization. * Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days before Cycle 1 Day 1. The patient can receive a stable dose of bisphosphonates or RANKL directed therapy for bone metastases before and during the study as long as these were initiated at least 2 weeks prior to study treatment * For Phase 2, not receiving FOLFIRINOX as initial therapy for metastatic PDAC. Patients who received FOLFIRINOX initially and who needed to discontinue irinotecan or oxaliplatin due to toxicity are eligible, provided they received at least 4 weeks (2 cycles) of FOLFIRINOX * For Phase 2, more than 1 prior line of therapy for metastatic PDAC * Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization * Any previous treatment with a HDAC inhibitor, including ivaltinostat

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Conditions

The condition(s) this trial relates to.

pancreatic adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic pancreatic adenocarcinoma

Contacts and locations

Locations

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Clinical Research Alliance

    Westbury, New York, 11590, United States

  • Community Health Network

    Indianapolis, Indiana, 46250, United States

  • Hoag Medical Group

    Newport Beach, California, 92663, United States

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

  • Norton Cancer Institute Audubon

    Louisville, Kentucky, 40217, United States

  • Penn State Hershey Cancer Institute

    Hershey, Pennsylvania, 17033, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • UCLA Hematology/Oncology, Gastrointestinal Oncology

    Santa Monica, California, 90404, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • University Cancer and Blood Center

    Athens, Georgia, 30607, United States

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84107, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.