Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
Public ClinicalTrials.gov record NCT00327327. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00327327
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2004
- Primary completion
- Sep 30, 2009
- Completion
- Sep 30, 2009
- Last update posted
- Sep 14, 2010
2004 – 2009
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | — |
| US Oncology Orlando, Cancer Centers of FL | Ocoee | Florida | 34761 | — |
| US Oncology Indiana | Indianapolis | Indiana | 46227 | — |
| Univ of Michigan | Ann Arbor | Michigan | 48109 | — |
| US Oncology Albany, New York Oncology | Albany | New York | 12208 | — |
| US Oncology Kettering | Kettering | Ohio | 45409 | — |
| Fox Chase Cancer Ctr. | Philadelphia | Pennsylvania | 19111 | — |
| US Oncology, Virginia Oncology Assoc | Norfolk | Virginia | 23502 | — |
| US Oncology Northwest, Northwest Cancer Specialists | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00327327, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2010 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00327327 live on ClinicalTrials.gov.