Overview
Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Advanced Life Sciences, Inc.
Criteria
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.