Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma

Study Overview
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Brief Summary
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A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.

Official Title
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Dose-escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Drug: ALS-357


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study Participants must be 18 years or older. Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be removed with surgery. Study Participants may have been previously treated with chemotherapy or immunotherapy but not with in 4 weeks of first dose of study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ALS-357 applied topically twice weekly for four weeks. | Drug: ALS-357<br>* Topical application of ALS-357<br>|
| Experimental: 2<br>ALS-357 applied topically every other day for four weeks. | Drug: ALS-357<br>* Topical application of ALS-357<br>|
| Experimental: 3<br>ALS-357 applied topically once daily for four weeks. | Drug: ALS-357<br>* Topical application of ALS-357<br>|
| Experimental: 4<br>ALS-357 applied topically twice daily for four weeks. | Drug: ALS-357<br>* Topical application of ALS-357<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma. |  | Day 8, 15, 22, 29 and 43 | 
| Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers. |  | Day 8, 15, 22, 29 and 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay. |  | Day 15, 29 and 43 | 
| Nucleic Acid will be isolated from portions of the biopsies to be utilized for gene expression profiling by various analytical platforms and correlated with other apoptotic in situ and surface protein expression pathways. |  | Day 15, 29 and 43 | 
| Evaluate the plasma concentration of ALS-357 at each scheduled study visit. |  | Day 1, 8, 15, 22, 29 and 43 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous Metastatic Melanoma