Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
Completed · Phase 1/Phase 2
Conditions studied: Malignant Melanoma
In brief
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 with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
Key facts
- Study ID
- NCT00327600
- Run by
- AmpliMed Corporation
- People needed
- 68
- Starts
- 2005-07-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2010-09-15
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- No prior chemotherapy for the stage III or IV disease.
- Brain metastases
Where it is running
- Investigational Site 009 — Los Angeles, California, United States
- Investigational Site 002 — Santa Monica, California, United States
- University of CO Anschutz Cancer Pavilion — Aurora, Colorado, United States
- US Oncology Orlando, Cancer Centers of FL — Ocoee, Florida, United States
- US Oncology Albany, New York Oncology — Albany, New York, United States
- US Oncology Kettering — Kettering, Ohio, United States
- US Oncology Greenville, Cancer Centers of the Carolinas — Greenville, South Carolina, United States
- US Oncology, Tyler Cancer Center — Tyler, Texas, United States
- Investigational Site 012 — Salt Lake City, Utah, United States
- US Oncology, Virginia Oncology Assoc — Norfolk, Virginia, United States
- US Oncology Spokane, Cancer Care Northwest — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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