Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
- Conditions
- Pancreatic Adenocarcinoma
- Registration Number
- NCT00327327
- Lead Sponsor
- AmpliMed Corporation
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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.
- Prior chemotherapy for metastatic disease.
- Brain metastases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine maximally tolerated dose (MTD) until MTD reached determine dose limiting toxicities. until MTD reached
- Secondary Outcome Measures
Name Time Method Changes in plasma thiol levels until MTD reached pharmacokinetics until MTD reached objective tumor responses. until MTD reached
Trial Locations
- Locations (9)
US Oncology Albany, New York Oncology
🇺🇸Albany, New York, United States
US Oncology Orlando, Cancer Centers of FL
🇺🇸Ocoee, Florida, United States
US Oncology Kettering
🇺🇸Kettering, Ohio, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
US Oncology Northwest, Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
US Oncology Indiana
🇺🇸Indianapolis, Indiana, United States
Univ of Michigan
🇺🇸Ann Arbor, Michigan, United States
Fox Chase Cancer Ctr.
🇺🇸Philadelphia, Pennsylvania, United States
US Oncology, Virginia Oncology Assoc
🇺🇸Norfolk, Virginia, United States