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NCT03608631 · ClinicalTrials.gov registry record · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
A Phase 1 study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT03608631: Recruiting Phase 1 study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03608631 is a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 28 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03608631, a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the best dose and side effects of mesenchymal stromal cells-derived exosomes with KrasG12D siRNA (iExosomes) in treating participants with pancreatic cancer with KrasG12D mutation that has spread to other places in the body. iExosomes may work better at treating pancreatic cancer.
Primary Outcome
Dose limiting toxicity graded according to the NCI CTCAE, Version 4.0
Conditions Studied
Interventions
- DRUG Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-01-27 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
What NCT03608631 shows while recruiting
NCT03608631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA is the first listed.
NCT03608631 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03608631 about?
NCT03608631 is a clinical study titled "iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation". This phase I trial studies the best dose and side effects of mesenchymal stromal cells-derived exosomes with KrasG12D siRNA (iExosomes) in treating participants with pancreatic cancer with KrasG12D mutation that has spread to other places in the body. iExosomes may work better at treating pancreatic...
What is the current status of trial NCT03608631?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-01-27. Estimated completion is 2027-04-30.
What conditions does trial NCT03608631 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8, KRAS NP_004976.2:p.G12D.
What interventions are being tested in trial NCT03608631?
The interventions under investigation include: Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA (DRUG).
Who is sponsoring clinical trial NCT03608631?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03608631 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03608631's enrollment target sits among peer trials
28 67th of 84 higher than 16 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal 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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