Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
Completed · Phase 1
Conditions studied: Pancreatic Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT00327327
- Run by
- AmpliMed Corporation
- People needed
- 105
- Starts
- 2004-02-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2010-09-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Prior chemotherapy for metastatic disease.
- Brain metastases
Where it is running
- Arizona Clinical Research Center — Tucson, Arizona, United States
- US Oncology Orlando, Cancer Centers of FL — Ocoee, Florida, United States
- US Oncology Indiana — Indianapolis, Indiana, United States
- Univ of Michigan — Ann Arbor, Michigan, United States
- US Oncology Albany, New York Oncology — Albany, New York, United States
- US Oncology Kettering — Kettering, Ohio, United States
- Fox Chase Cancer Ctr. — Philadelphia, Pennsylvania, United States
- US Oncology, Virginia Oncology Assoc — Norfolk, Virginia, United States
- US Oncology Northwest, Northwest Cancer Specialists — Vancouver, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.