Study of Ivaltinostat Plus Capecitabine or Capecitabine Alone in Metastatic Pancreatic Cancer

Sponsor: CG Pharmaceuticals, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05249101

Provider View

This clinical trial is testing a new treatment combination of ivaltinostat and capecitabine, compared to capecitabine alone, for patients with metastatic pancreatic cancer who have not shown disease progression after initial chemotherapy.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of combining ivaltinostat with capecitabine, as well as capecitabine alone, in patients with metastatic pancreatic cancer. The trial is divided into two phases: Phase 1b will determine the best dose of ivaltinostat, and Phase 2 will compare the combination treatment to capecitabine alone. Patients will receive treatment in cycles, with regular assessments to monitor tumor response.

Description

This study involves two phases to test a new treatment for metastatic pancreatic cancer. In Phase 1b, researchers will test three different doses of ivaltinostat combined with a fixed dose of capecitabine to find the best dose for future use. In Phase 2, patients will be randomly assigned to receive either the combination of ivaltinostat and capecitabine or capecitabine alone.

Patients will take capecitabine orally twice a day for 14 days, followed by a 7-day rest period, making up a 21-day treatment cycle. Ivaltinostat will be given through an IV once a week for two weeks, followed by a week of rest. Tumor response will be checked every 6 weeks initially, then every 9 weeks, using scans to see how the cancer is responding to the treatment.

The study will include about 70 patients, with 18 in Phase 1b and 52 in Phase 2. Patients will continue treatment until their cancer progresses or they experience unacceptable side effects. After stopping treatment, patients will be followed up every 8 weeks to monitor their health and any further treatments they receive.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of pancreatic cancer that has spread or is locally advanced.
  • For Phase 1b, must have had at least one prior therapy for advanced cancer.
  • For Phase 2, must not have shown disease progression after initial chemotherapy for metastatic cancer.
  • Must have received FOLFIRINOX chemotherapy for at least 16 weeks without disease progression.
  • Must have adequate organ function and a good performance status.
  • Must have completed any prior radiation therapy at least 14 days before starting the study.

Exclusion Criteria

  • For Phase 2, showing disease progression after initial chemotherapy.
  • Receiving any other chemotherapy or targeted therapy within 28 days before starting the study.
  • Not having received FOLFIRINOX as initial therapy for metastatic cancer.
  • Having more than one prior line of therapy for metastatic cancer.
  • Having taken an investigational drug within 30 days before starting the study.
  • Previous treatment with an HDAC inhibitor, including ivaltinostat.

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