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NCT01488552 · ClinicalTrials.gov registry record · Phase 1

Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer

A Phase 1 study of Stage IV Pancreatic Cancer, sponsored by Pancreatic Cancer Research Team.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
5
Study locations

NCT01488552: Completed Phase 1 study of Stage IV Pancreatic Cancer, sponsored by Pancreatic Cancer Research Team.

NCT01488552 is a Phase 1 study of Stage IV Pancreatic Cancer that has completed, run by Pancreatic Cancer Research Team. The registered enrollment target is 60 participants, below the 75-participant average among 15 other Stage IV Pancreatic Cancer trials with a reported enrollment target (20% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01488552, a Phase 1 study of Stage IV Pancreatic Cancer, has completed, sponsored by Pancreatic Cancer Research Team.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
5
Study locations

Study Summary

The Investigators in the PCRT team have developed a therapeutic regimen which attacks both the tumor compartment and the stromal compartment of pancreatic cancer and induces complete responses in a small percentage of patients with advanced stage IV pancreatic cancer.

Primary Outcome

The primary objectives of this study are to relentlessly pursue treatment for 34 individual patients with Stage IV pancreatic cancer to obtain: • The complete response rate (as defined by a complete metabolomic response (CMR) of SUV normalization from baseline, OR a complete response on CT scan using a modified RECIST criteria and CA 19-9 (or CA 125, CEA, or PAM4 if not expressers of CA 19-9) down to normal limits (from at least \> 2X ULN).

Conditions Studied

Interventions

  • DRUG Metformin
  • DRUG Gemcitabine
  • DRUG nab-paclitaxel
  • DRUG FOLFIRINOX
  • GENETIC Immunohistochemistry (IHC) Analysis

Study Locations (5)

Washington

  • Virginia Mason Medical Center - Seattle
  • Evergreen Hematology and Oncology - Spokane

Arizona

  • TGen Clinical Research Services (TCRS) - Scottsdale

California

  • Disney Family Cancer Center - Burbank

Minnesota

  • Virginia Piper Cancer Institute (VPCI) - Minneapolis

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-11
Est. Completion 2016-08
Phase Phase 1
Pancreatic Cancer Research Team

5 total trials

What the finished NCT01488552 record still lists

NCT01488552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 75-participant average among 15 other Stage IV Pancreatic Cancer trials with a reported enrollment target (20% lower).

The record links to 1 condition, with Stage IV Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Metformin is the first listed.

NCT01488552 lists 5 locations in 4 states (Washington, Arizona, California).

Frequently Asked Questions

What is clinical trial NCT01488552 about?

NCT01488552 is a clinical study titled "Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer". The Investigators in the PCRT team have developed a therapeutic regimen which attacks both the tumor compartment and the stromal compartment of pancreatic cancer and induces complete responses in a small percentage of patients with advanced stage IV pancreatic cancer.

What is the current status of trial NCT01488552?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-11. Estimated completion is 2016-08.

What conditions does trial NCT01488552 study?

This clinical trial studies the following conditions: Stage IV Pancreatic Cancer.

What interventions are being tested in trial NCT01488552?

The interventions under investigation include: Metformin (DRUG), Gemcitabine (DRUG), nab-paclitaxel (DRUG), FOLFIRINOX (DRUG), Immunohistochemistry (IHC) Analysis (GENETIC).

Who is sponsoring clinical trial NCT01488552?

This trial is sponsored by Pancreatic Cancer Research Team, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01488552 being conducted?

This trial has 5 study locations across Arizona, California, Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stage IV Pancreatic Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01488552's enrollment target sits among peer trials

60 5th of 15 higher than 11 of 15 other Stage IV Pancreatic Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Pancreatic Cancer 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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Source: ClinicalTrials.gov NCT01488552, the US trial registry maintained by the National Library of Medicine. NCT01488552 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.