NCT00327327CompletedPhase 1
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AmpliMed Corporation
- Enrollment
- 105
- Locations
- 9
- Primary Endpoint
- Determine maximally tolerated dose (MTD)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Determine maximally tolerated dose (MTD)
Time Frame: until MTD reached
determine dose limiting toxicities.
Time Frame: until MTD reached
Secondary Outcomes
- Changes in plasma thiol levels(until MTD reached)
- pharmacokinetics(until MTD reached)
- objective tumor responses.(until MTD reached)
Investigators
Study Sites (9)
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