Back to resultsSafety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
Primary Purpose
Neoplasm Metastasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
imexon
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Metastatic cancer, Disseminated malignant disease
Eligibility Criteria
Inclusion Criteria: Previously treated malignant disease of any type. Prior treatment; at least one prior regimen required. Able to perform the activities of daily living. Off prior cancer therapy for at least 4 weeks. 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 other current drug therapy for the cancer. Blood counts and blood chemistries in or near normal range. Prior radiation is permitted. Exclusion Criteria: No active brain metastases.
Sites / Locations
- US Oncology Indiana
- US Oncology Albany, New York Oncology
- Investigational Site 014
- US Oncology, Tyler Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
imexon
Arm Description
Dose escalation of imexon
Outcomes
Primary Outcome Measures
Determine the maximally tolerated dose
determine the pharmacokinetics
determine the toxicity of the drug on the designated schedule
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327223
Brief Title
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
Official Title
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AmpliMed Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
Keywords
Metastatic cancer, Disseminated malignant disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
imexon
Arm Type
Experimental
Arm Description
Dose escalation of imexon
Intervention Type
Drug
Intervention Name(s)
imexon
Primary Outcome Measure Information:
Title
Determine the maximally tolerated dose
Title
determine the pharmacokinetics
Title
determine the toxicity of the drug on the designated schedule
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previously treated malignant disease of any type.
Prior treatment; at least one prior regimen required.
Able to perform the activities of daily living.
Off prior cancer therapy for at least 4 weeks.
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 other current drug therapy for the cancer.
Blood counts and blood chemistries in or near normal range.
Prior radiation is permitted.
Exclusion Criteria:
No active brain metastases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Hersh, MD
Organizational Affiliation
AmpliMed Corporation
Official's Role
Study Director
Facility Information:
Facility Name
US Oncology Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
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
Investigational Site 014
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
US Oncology, Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
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