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NCT03087591 · ClinicalTrials.gov registry record · Phase 1
APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03087591: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT03087591 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03087591, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Will be categorized by organ system and severity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Related treatment emergent adverse events by maximum severity. Unexpected grade 4 and all grade 5 events are considered severe adverse events. CTCAE grades 3-5 allergic reactions related to study cell infusion CTCAE grades 3 and greater autoimmune reactions other than that vitiligo CTCAE grades 3 and greater organ toxicity (cardiac, dermatologic, ga
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL siRNA-transfected Peripheral Blood Mononuclear Cells (PBMC) APN401
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-04-28 |
| Est. Completion | 2020-12-08 |
| Phase | Phase 1 |
What the finished NCT03087591 record still lists
NCT03087591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03087591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03087591 about?
NCT03087591 is a clinical study titled "APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed f...
What is the current status of trial NCT03087591?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2017-04-28. Estimated completion is 2020-12-08.
What interventions are being tested in trial NCT03087591?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), siRNA-transfected Peripheral Blood Mononuclear Cells (PBMC) APN401 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03087591?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03087591's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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