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Sponsored by: |
Advanced Life Sciences, Inc. |
Information provided by: | Advanced Life Sciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00701987 |
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.
Condition | Intervention | Phase |
Melanoma |
Drug: ALS-357 |
Phase I |
MedlinePlus related topics: | Melanoma |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Dose-Escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma |
Estimated Enrollment: | 12 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
ALS-357 applied topically twice weekly for four weeks.
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Drug: ALS-357
Topical application of ALS-357
|
2: Experimental
ALS-357 applied topically every other day for four weeks.
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Drug: ALS-357
Topical application of ALS-357
|
3: Experimental
ALS-357 applied topically once daily for four weeks.
|
Drug: ALS-357
Topical application of ALS-357
|
4: Experimental
ALS-357 applied topically twice daily for four weeks.
|
Drug: ALS-357
Topical application of ALS-357
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Timothy Kuzel, MD | 312-695-1301 |
United States, Illinois | |||||
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Recruiting | ||||
Chicago, Illinois, United States, 60611 | |||||
Contact: Timothy Kuzel, MD 312-695-1301 | |||||
Principal Investigator: Timothy Kuzel, MD | |||||
Sub-Investigator: Mario LaCouture, MD |
Advanced Life Sciences, Inc. |
Principal Investigator: | Timothy Kuzel, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Advanced Life Sciences ( David A. Eiznhamer, Executive Vice President, Clinical Development ) |
Study ID Numbers: | ALS-357-001 |
First Received: | June 17, 2008 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00701987 |
Health Authority: | United States: Food and Drug Administration |
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