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NCT05034627 · ClinicalTrials.gov registry record · Phase 1
Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
A Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by OHSU Knight Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05034627: Active Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by OHSU Knight Cancer Institute.
NCT05034627 is a Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8 that is active but no longer recruiting, run by OHSU Knight Cancer Institute. The registered enrollment target is 15 participants, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05034627, a Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, is active but no longer recruiting, sponsored by OHSU Knight Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of calaspargase pegol-mknl in combination with cobimetinib in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cobimetinib attacks a protein called MEK that has been known to stimulate cells that promote the growth of cancer cells in the body. Calaspargase pegol-mknl is an enzyme that converts the amino acid L-asparagine into aspartic acid and ammonia. Many types of cancer cell rely on the amino acid L-asparagine, and depleting this amino acid with calaspargase pegol-mknl starves cancer cells of this nutrient. Attacking the MEK protein with cobimetinib is thought to further prevent cancer cells from using this amino acid, causing them to die. Giving calaspargase pegol-mknl in combination with cobimetinib may help control the disease in patients with pancreatic cancer.
Primary Outcome
Defined as any treatment-related grade \>= 3 non-hematological or hematological adverse events. The incidence of DLT at each dose level will be summarized using the proportion and exact binomial confidence interval. Dose-limiting toxicities will specifically be reported for the DLT evaluation period using the maximum tolerated dose (MTD)-evaluable population. The MTD will be identified using isotonic regression.
Conditions Studied
Interventions
- PROCEDURE Biopsy
- DRUG Cobimetinib
- DRUG Calaspargase Pegol-mknl
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-08-09 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 1 |
What the registry record for NCT05034627 still lists
NCT05034627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (83% lower).
The record links to 7 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Biopsy is the first listed.
NCT05034627 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT05034627 about?
NCT05034627 is a clinical study titled "Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer". This phase I trial tests the safety, side effects, and best dose of calaspargase pegol-mknl in combination with cobimetinib in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cobimetin...
What is the current status of trial NCT05034627?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-08-09. Estimated completion is 2026-10-01.
What conditions does trial NCT05034627 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Locally Advanced Pancreatic Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8.
What interventions are being tested in trial NCT05034627?
The interventions under investigation include: Biopsy (PROCEDURE), Cobimetinib (DRUG), Calaspargase Pegol-mknl (DRUG).
Who is sponsoring clinical trial NCT05034627?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05034627 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05034627's enrollment target sits among peer trials
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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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