Status:
COMPLETED
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
Lead Sponsor:
AmpliMed Corporation
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- No active brain metastases.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00327223
Start Date
November 1 2005
End Date
October 1 2006
Last Update
March 14 2008
Active Locations (4)
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1
US Oncology Indiana
Indianapolis, Indiana, United States, 46227
2
US Oncology Albany, New York Oncology
Albany, New York, United States, 12208
3
Investigational Site 014
Temple, Texas, United States, 76508
4
US Oncology, Tyler Cancer Center
Tyler, Texas, United States, 75702