Back to resultsSafety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
Primary Purpose
Pancreatic Adenocarcinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
imexon
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Arizona Clinical Research Center
- US Oncology Orlando, Cancer Centers of FL
- US Oncology Indiana
- Univ of Michigan
- US Oncology Albany, New York Oncology
- US Oncology Kettering
- Fox Chase Cancer Ctr.
- US Oncology, Virginia Oncology Assoc
- US Oncology Northwest, Northwest Cancer Specialists
Outcomes
Primary Outcome Measures
Determine maximally tolerated dose (MTD)
determine dose limiting toxicities.
Secondary Outcome Measures
Changes in plasma thiol levels
pharmacokinetics
objective tumor responses.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327327
Brief Title
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
Official Title
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AmpliMed Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
imexon
Intervention Description
30-60 minutes IV, days 1,8,15 every 28 days
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
30 minutes IV, days 1,8,15 every 28 days
Primary Outcome Measure Information:
Title
Determine maximally tolerated dose (MTD)
Time Frame
until MTD reached
Title
determine dose limiting toxicities.
Time Frame
until MTD reached
Secondary Outcome Measure Information:
Title
Changes in plasma thiol levels
Time Frame
until MTD reached
Title
pharmacokinetics
Time Frame
until MTD reached
Title
objective tumor responses.
Time Frame
until MTD reached
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Zalupski, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Cohen, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
US Oncology Orlando, Cancer Centers of FL
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
US Oncology Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Univ of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
US Oncology Albany, New York Oncology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
US Oncology Kettering
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Fox Chase Cancer Ctr.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
US Oncology, Virginia Oncology Assoc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
US Oncology Northwest, Northwest Cancer Specialists
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19855966
Citation
Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007/s00280-009-1162-y. Epub 2009 Oct 24.
Results Reference
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Learn more about this trial
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
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