Malignant Melanoma
Conditions
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 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.
Sponsors
AmpliMed Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* No prior chemotherapy for the stage III or IV disease. * Brain metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximally tolerated dose of imexon plus DTIC | — |
| determine the toxicity and tolerability of the combination | — |
| determine response rate and progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine effects of the drug combination on plasma thiol levels and other biomarkers | — |
Countries
United States
Outcome results
None listed