A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic Adenocarcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Ivaltinostat: Ivaltinostat (E)-N1-(3-(dimethylamino)propyl)-N8-hydroxy-2-((naphthalen-1-yloxy)methyl)oct-2-enediamide phosphate) is a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase (HDAC).
Capecitabine: Capecitabine is labeled for monotherapy for the treatment of adjuvant Dukes' C colon cancer and metastatic colon cancer at a recommended dose of 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest. This dose schedule was effective and tolerable in the first line setting for patients with pancreatic cancer (Cartwright, 2002).
Study summary
This study is a Phase 1b/2, dose-escalation, randomized, multicenter study to assess the efficacy, safety, tolerability, and PK of ivaltinostat in combination with capecitabine and capecitabine monotherapy in patients with metastatic pancreatic adenocarcinoma whose disease has not progressed on a first line fluoropyrimidine-based chemotherapy (e.g., FOLFIRINOX).
In Phase 1b, 3 dose levels of ivaltinostat will be studied in combination with a fixed dose of capecitabine to determine the RP2D of ivaltinostat.
In Phase 2, patients will be randomized in a 1:1 ratio to the combination of ivaltinostat and capecitabine or to capecitabine monotherapy. A fixed dose for capecitabine 1000 mg/m2 orally twice daily will be taken on Days 1 to 14, and the RP2D of ivaltinostat will be administered intravenously once a week for 2 weeks, followed by 1 week of rest. One cycle consists of 21 days. Tumor response during study treatment will be assessed every 6 weeks up to Cycle 10, then every 9 weeks afterwards using RECIST v1.1 criteria.
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicities (DLTs) in phase 1 — 15 months
The percentage of subjects who experience a grade 3 or higher adverse event that qualifies as a DLT - Incidence of treatment emergent AEs in phase 1 — 15 months
The number of subjects who experience an adverse event that was possibly related to study drug - Treatment emergent changes in clinical laboratory tests in phase 1 — 15 months
The number of subjects who experience a change in laboratory parameters that was possibly related to study drug. - Progression-Free Survival (PFS) in Phase 2 — 15 months
Investigator assessed PFS
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | |
| Hoag Medical Group | Newport Beach | California | |
| UCSF Medical Center | San Francisco | California | |
| UCLA Hematology/Oncology, Gastrointestinal Oncology | Santa Monica | California | |
| University Cancer and Blood Center | Athens | Georgia | |
| Community Health Network | Indianapolis | Indiana | |
| Norton Cancer Institute Audubon | Louisville | Kentucky | |
| University Medical Center New Orleans | New Orleans | Louisiana | |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | |
| Clinical Research Alliance | Westbury | New York | |
| Penn State Hershey Cancer Institute | Hershey | Pennsylvania | |
| The University of Texas Southwestern Medical Center | Dallas | Texas | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Utah Cancer Specialists | Salt Lake City | Utah | |
| Virginia Cancer Specialists | Fairfax | Virginia |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05249101 on ClinicalTrials.gov ↗ ← All trials in the USA