Status:
COMPLETED
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
Lead Sponsor:
AmpliMed Corporation
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 untr...
Eligibility Criteria
Inclusion
- Inoperable cancer of the pancreas.
- Blood cell counts and blood chemistries in or near normal range.
- Able to perform the activities of daily living.
- A projected life expectancy of at least 2 months.
- If female, neither pregnant nor nursing.
- Willing to use contraceptives to prevent pregnancy.
- No other serious illnesses.
- No other active malignancy.
- No serious infections.
- No current other drug therapy for the cancer or steroid therapy.
- Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.
Exclusion
- Prior chemotherapy for metastatic disease.
- Brain metastases
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00327327
Start Date
February 1 2004
End Date
October 1 2009
Last Update
September 15 2010
Active Locations (9)
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1
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
2
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, United States, 34761
3
US Oncology Indiana
Indianapolis, Indiana, United States, 46227
4
Univ of Michigan
Ann Arbor, Michigan, United States, 48109