Pancreatic Adenocarcinoma
Conditions
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.
Interventions
DRUGimexon
30-60 minutes IV, days 1,8,15 every 28 days
DRUGgemcitabine
30 minutes IV, days 1,8,15 every 28 days
Sponsors
AmpliMed Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Prior chemotherapy for metastatic disease. * Brain metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine maximally tolerated dose (MTD) | until MTD reached |
| determine dose limiting toxicities. | until MTD reached |
Secondary
| Measure | Time frame |
|---|---|
| Changes in plasma thiol levels | until MTD reached |
| pharmacokinetics | until MTD reached |
| objective tumor responses. | until MTD reached |
Countries
United States
Outcome results
None listed