drugset / Trial / NCT00701987

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

NCT00701987 ↗

Phase 1 Unknown 12 enrolled Advanced Life Sciences, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-06
Primary completion
2009-06
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Betulinic Acid Small molecule — Topical

Indications