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NCT02487277 · ClinicalTrials.gov registry record · Phase 2
PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma
A Phase 2 study, sponsored by Andrew Ko.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02487277: Clinical Trial Phase 2 study, sponsored by Andrew Ko.
NCT02487277 is a Phase 2 study that was terminated before completion, run by Andrew Ko. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02487277, a Phase 2 study, was terminated before completion, sponsored by Andrew Ko.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
We will be conducting a Phase II study investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) at the Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco (UCSF). There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable PDAC cases will be identified per the definition developed in the currently running inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this trial, borderline resectable PDAC is defined as "presence of any one or more of the following on CT: * An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring ≥ 180° of the circumference of the vessel wall * Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction * Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction. * An interface between the tumor, and Superior mesenteric artery (SMA) measuring \< 180º of the circumference of the vessel wall. This trial will be conducted in two parts. In Part I, pre-treatment endoscopic ultrasound (EUS)-guided core biopsies of the pancreatic tumor, CA 19-9 levels and functional MRIs including Dynamic contrast-enhanced (DCE)-MRI and Diffusion-weighted magnetic resonance imaging (DWI-MRI) will be obtained for the first fifteen patients enrolled. After a 1-week run-in period with PEGPH20 on days 1 and 4, patients will have repeat EUS-guided core biopsies, functional MRI, CA 19-9 level
Primary Outcome
Our study will be investigating only clinically relevant pancreatic fistulas, i.e. grades B or C. Descriptive statistics will be used report the incidence of pancreatic fistula within the 7-day post-operative period after neoadjuvant treatment
Interventions
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG PEGPH20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-07-14 |
| Est. Completion | 2018-05-18 |
| Phase | Phase 2 |
Why NCT02487277 stopped before completion
NCT02487277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT02487277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02487277 about?
NCT02487277 is a clinical study titled "PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma". We will be conducting a Phase II study investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) at the Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco (UCSF). The...
What is the current status of trial NCT02487277?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2015-07-14. Estimated completion is 2018-05-18.
What interventions are being tested in trial NCT02487277?
The interventions under investigation include: Gemcitabine (DRUG), Nab-paclitaxel (DRUG), PEGPH20 (DRUG).
Who is sponsoring clinical trial NCT02487277?
This trial is sponsored by Andrew Ko, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02487277's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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