Status:
COMPLETED
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
Lead Sponsor:
AmpliMed Corporation
Conditions:
Malignant Melanoma
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients w...
Eligibility Criteria
Inclusion
- Malignant melanoma; inoperable stage III or IV disease.
- Able to perform the activities of daily living.
- A projected life expectancy of at least 4 months.
- If female, neither pregnant nor nursing.
- Willing to use contraceptives to prevent pregnancy.
- Blood cell counts and blood chemistries in or near normal range.
- Prior radiation is permitted.
- No other serious illnesses.
- No other active malignancy.
- No serious infections.
- No other current drug therapy for the cancer or steroid therapy.
Exclusion
- No prior chemotherapy for the stage III or IV disease.
- Brain metastases
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00327600
Start Date
July 1 2005
End Date
December 1 2007
Last Update
September 15 2010
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site 009
Los Angeles, California, United States, 90033
2
Investigational Site 002
Santa Monica, California, United States, 90404
3
University of CO Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80010
4
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, United States, 34761