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

Advanced Life Sciences

Status and phase: Unknown; Phase 1

Conditions: Melanoma

Treatments: Drug: ALS-357

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701987

ALS-357-001

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

1

Experimental group

Description:

ALS-357 applied topically twice weekly for four weeks.

Treatment:

Drug: ALS-357

2

Experimental group

Description:

ALS-357 applied topically every other day for four weeks.

Treatment:

Drug: ALS-357

3

Experimental group

Description:

ALS-357 applied topically once daily for four weeks.

Treatment:

Drug: ALS-357

4

Experimental group

Description:

ALS-357 applied topically twice daily for four weeks.

Treatment:

Drug: ALS-357