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NCT00327327 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
A Phase 1 study of Pancreatic Adenocarcinoma, sponsored by AmpliMed Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
- 9
- Study locations
NCT00327327: Completed Phase 1 study of Pancreatic Adenocarcinoma, sponsored by AmpliMed Corporation.
NCT00327327 is a Phase 1 study of Pancreatic Adenocarcinoma that has completed, run by AmpliMed Corporation. The registered enrollment target is 105 participants, below the 99,463-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00327327, a Phase 1 study of Pancreatic Adenocarcinoma, has completed, sponsored by AmpliMed Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
- 9
- Study locations
Study Summary
AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.
Conditions Studied
Interventions
- DRUG gemcitabine
- DRUG imexon
Study Locations (9)
Arizona
- Arizona Clinical Research Center - Tucson
Florida
- US Oncology Orlando, Cancer Centers of FL - Ocoee
Indiana
- US Oncology Indiana - Indianapolis
Michigan
- Univ of Michigan - Ann Arbor
New York
- US Oncology Albany, New York Oncology - Albany
Ohio
- US Oncology Kettering - Kettering
Pennsylvania
- Fox Chase Cancer Ctr. - Philadelphia
Virginia
- US Oncology, Virginia Oncology Assoc - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2004-02 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00327327 record still lists
NCT00327327 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 99,463-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which gemcitabine is the first listed.
NCT00327327 lists 9 locations in 9 states (Arizona, Florida, Indiana).
Frequently Asked Questions
What is clinical trial NCT00327327 about?
NCT00327327 is a clinical study titled "Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma". AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1...
What is the current status of trial NCT00327327?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2004-02. Estimated completion is 2009-10.
What conditions does trial NCT00327327 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT00327327?
The interventions under investigation include: gemcitabine (DRUG), imexon (DRUG).
Who is sponsoring clinical trial NCT00327327?
This trial is sponsored by AmpliMed Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00327327 being conducted?
This trial has 9 study locations across Arizona, Florida, Indiana, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00327327's enrollment target sits among peer trials
105 22nd of 62 higher than 41 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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