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Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

NCT00327327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2010-09-15

No results posted yet for this 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

  • Pancreatic Adenocarcinoma

Interventions

DRUG

imexon

30-60 minutes IV, days 1,8,15 every 28 days

DRUG

gemcitabine

30 minutes IV, days 1,8,15 every 28 days

Sponsors & Collaborators

  • AmpliMed Corporation

    lead INDUSTRY

Principal Investigators

  • Mark Zalupski, MD · University of Michigan

  • Steven Cohen, MD · Fox Chase Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00327327 on ClinicalTrials.gov