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NCT05249101 · ClinicalTrials.gov registry record · Phase 1
A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic Adenocarcinoma
A Phase 1 study of Metastatic Pancreatic Adenocarcinoma, sponsored by CG Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 16
- Study locations
NCT05249101: Active Phase 1 study of Metastatic Pancreatic Adenocarcinoma, sponsored by CG Pharmaceuticals.
NCT05249101 is a Phase 1 study of Metastatic Pancreatic Adenocarcinoma that is active but no longer recruiting, run by CG Pharmaceuticals. The registered enrollment target is 70 participants, below the 88-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (20% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05249101, a Phase 1 study of Metastatic Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by CG Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 16
- Study locations
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.
Primary Outcome
The percentage of subjects who experience a grade 3 or higher adverse event that qualifies as a DLT
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Ivaltinostat
Study Locations (16)
California
- Hoag Medical Group - Newport Beach
- UCSF Medical Center - San Francisco
- UCLA Hematology/Oncology, Gastrointestinal Oncology - Santa Monica
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Clinical Research Alliance - Westbury
Texas
- The University of Texas Southwestern Medical Center - Dallas
- The University of Texas MD Anderson Cancer Center - Houston
Arizona
- HonorHealth Research Institute - Scottsdale
Georgia
- University Cancer and Blood Center - Athens
Indiana
- Community Health Network - Indianapolis
Kentucky
- Norton Cancer Institute Audubon - Louisville
Louisiana
- University Medical Center New Orleans - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What the registry record for NCT05249101 still lists
NCT05249101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 88-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.
NCT05249101 lists 16 locations in 12 states (California, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT05249101 about?
NCT05249101 is a clinical study titled "A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic Adenocarcinoma". 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 fi...
What is the current status of trial NCT05249101?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2022-08-15. Estimated completion is 2026-07.
What conditions does trial NCT05249101 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT05249101?
The interventions under investigation include: Capecitabine (DRUG), Ivaltinostat (DRUG).
Who is sponsoring clinical trial NCT05249101?
This trial is sponsored by CG Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05249101 being conducted?
This trial has 16 study locations across Arizona, California, Georgia, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05249101's enrollment target sits among peer trials
70 12th of 37 higher than 26 of 37 other Metastatic Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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