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NCT05624918 · ClinicalTrials.gov registry record · Phase 2
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
A Phase 2 study of Pancreatic Adenocarcinoma and Resectable Pancreatic Cancer, sponsored by Ashish Manne.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT05624918: Recruiting Phase 2 study of Pancreatic Adenocarcinoma and Resectable Pancreatic Cancer, sponsored by Ashish Manne.
NCT05624918 is a Phase 2 study of Pancreatic Adenocarcinoma and Resectable Pancreatic Cancer that is actively recruiting participants, run by Ashish Manne. The registered enrollment target is 38 participants, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05624918, a Phase 2 study of Pancreatic Adenocarcinoma and Resectable Pancreatic Cancer, is actively recruiting participants, sponsored by Ashish Manne.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.
Primary Outcome
Determine the two-year OS rate. Two-year (2-Y) OS will be calculated as the percentage of patients who remain alive at the 2 year mark from the registration date.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Nab paclitaxel
- DEVICE NovoTTF-200T(P)
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What NCT05624918 shows while recruiting
NCT05624918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Gemcitabine is the first listed.
NCT05624918 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05624918 about?
NCT05624918 is a clinical study titled "A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma". This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patient...
What is the current status of trial NCT05624918?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2024-07-01. Estimated completion is 2028-08.
What conditions does trial NCT05624918 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Resectable Pancreatic Cancer.
What interventions are being tested in trial NCT05624918?
The interventions under investigation include: Gemcitabine (DRUG), Nab paclitaxel (DRUG), NovoTTF-200T(P) (DEVICE).
Who is sponsoring clinical trial NCT05624918?
This trial is sponsored by Ashish Manne, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05624918 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05624918's enrollment target sits among peer trials
38 42nd of 62 higher than 21 of 62 other Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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