Clinical trial · Interventional
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DTIC | Drug | Dacarbazine | ALIAS |
| imexon | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- imexon + DTIC
- interventionNames
- Drug: imexon
- Drug: DTIC
Primary outcomes (3)
- measure
- Determine the maximally tolerated dose of imexon plus DTIC
- measure
- determine the toxicity and tolerability of the combination
- measure
- determine response rate and progression free survival
Secondary outcomes (1)
- measure
- Determine effects of the drug combination on plasma thiol levels and other biomarkers
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- RESULTWeber JS, Samlowski WE, Gonzalez R, Ribas A, Stephenson J, O'Day S, Sato T, Dorr R, Grenier K, Hersh E. A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer. 2010 Aug 1;116(15):3683-91. doi: 10.1002/cncr.25119. PMID 20564083