AmpliMed Patients and Trials, Amplimed is a cancer research chemotherapy corporation with a drug class that features novel mechanisms of action that can defeat MDR and some toxicities

Pancreatic Cancer

Protocol AMP-019

AMP-019 is a randomized placebo-controlled, double blind Phase II trial designed to evaluate the effectiveness and safety of Amplimexon® in combination with gemcitabine compared to gemcitabine alone, for the treatment of patients with previously untreated advanced pancreatic cancer. The treatment consists of dosing with both Amplimexon® and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the effect of the combination on overall survival compared to single agent therapy as the primary endpoint and the effect on progression-free survival and response rate as the secondary end points. The study is being conducted in multiple centers in the U.S. and has completed patient enrollment with a total of 142 patients.

Who can participate?

In order to participate in the study, a patient had to meet the following criteria

Inoperable metastatic (advanced) cancer of the pancreas.
Blood cell counts and blood chemistries at 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 active malignancy.
No other serious illnesses.
No prior chemotherapy for metastatic disease.
No current other drug therapy for the cancer, or concurrent steroid therapy.
Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.

Please note there are also additional criteria. The study centers determine if patients meet all of the requirements for enrollment.

Risks

While gemcitabine is known to benefit some patients with pancreatic cancer, the efficiency, if any of the combination of gemcitabine and Amplimexon have not yet been established. There may be side effects that are not known or not predicted at this time, but that may occur at the time of treatment or later.

Further information

For more information on AMP-019 or to find the location of the clinical trial sites, please click here.