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NCT04581343 · ClinicalTrials.gov registry record · Phase 1
A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (PC) Patients
A Phase 1 study, sponsored by Pancreatic Cancer Action Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04581343: Completed Phase 1 study, sponsored by Pancreatic Cancer Action Network.
NCT04581343 is a Phase 1 study that has completed, run by Pancreatic Cancer Action Network. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04581343, a Phase 1 study, has completed, sponsored by Pancreatic Cancer Action Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb), and spartalizumab (PDR001), a mAb directed against human Programmed Death-1 (PD-1), with the chemotherapy combination of gemcitabine and nab-paclitaxel. This study will confirm for this 4-drug combination the tolerable doses, the acceptable safety profile, and the dose to be used for a Phase II combination treatment regimen.
Primary Outcome
Evaluate dose limiting toxicities of patients with metastatic pancreatic cancer for at least 56 days (DLT period) after dosing with canakinumab at 250 mg every 4 weeks (Q4W), 400mg Spartalizumab Q4W and Gemcitabine/nab-paclitaxel on Days 1, 8 and 15 at standard of care levels. Dose limiting toxicities were evaluated to determine if dosing of canakinumab at 250 mg every 4 weeks with the other three drugs was considered tolerable and should be the dose utilized for future Phase 2/3 clinical trials
Interventions
- DRUG Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2023-02-27 |
| Phase | Phase 1 |
What the finished NCT04581343 record still lists
NCT04581343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine is the first listed.
NCT04581343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04581343 about?
NCT04581343 is a clinical study titled "A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (PC) Patients". This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb), and spartalizumab (PDR001), a mAb directed against human Programmed Death-1 (PD-1), with the chemotherapy combination of gemcitabine and nab-paclitaxel. This study will confirm for ...
What is the current status of trial NCT04581343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-11-02. Estimated completion is 2023-02-27.
What interventions are being tested in trial NCT04581343?
The interventions under investigation include: Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine (DRUG).
Who is sponsoring clinical trial NCT04581343?
This trial is sponsored by Pancreatic Cancer Action Network, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04581343's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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