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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00701987

Enrollment

Registered

2008-06-19

Start date

2008-06-30

Completion date

Unknown

Last updated

2010-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Cutaneous Metastatic Melanoma

Brief summary

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.

Interventions

DRUGALS-357

Topical application of ALS-357

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Contacts

Primary ContactTimothy Kuzel, MD

312-695-1301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026