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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 is a Phase 2 study that was terminated before completion, run by Andrew Ko. The registered enrollment target is 3 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02487277
The ClinicalTrials.gov registry entry for NCT02487277 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Andrew Ko, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT02487277 reports 0 study locations.
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.
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