A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic Adenocarcinoma (NCT05249101)
A Phase 1b/2, Dose-escalation, Randomized, Multicenter Study of Maintenance Ivaltinostat Plus Capecitabine or Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on FOLFIRINOX
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: HonorHealth Research Institute — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Pancreatic Adenocarcinoma
- A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer — Seattle, Washington
- Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread — Birmingham, Alabama
- Trial of Immunotherapy With Avelumab and Pepinemab As Second Line For Patients With Metastatic Pancreatic Adenocarcinoma — Rochester, New York
- Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations — Anchorage, Alaska
- Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer — Columbus, Ohio
Explore by condition: All Metastatic Pancreatic Adenocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.