Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

AmpliMed

Status and phase

Completed

Phase 1

Conditions

Pancreatic Adenocarcinoma

Treatments

Drug: imexon

Drug: gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327327

AMP-004

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.