NCT01321437

Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma

Phase 2 Study of the Anti-Angiogenesis Agent Axitinib (AG-013736) in Patients With Stage III Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine the efficacy of Axitinib in treating individuals with Stage III melanoma.

Detailed description

The American Cancer Society estimates that there will be about 68,720 new cases of melanoma (29,900 in men and 25,200 in women) annually in the United States, and about 8,650 people will die from this cancer. The systemic therapy of advanced disease remains palliative until new agents are found that might improve the survival of patients with stage III melanoma. Melanomas are often vascular, and a decrease in the number of blood vessels that supply the tumor may starve it of needed nutrients. An approach to blocking the growth of blood vessels that supply the tumor is to inhibit the vascular endothelial growth factor receptor tyrosine kinase (VEGFR TK) signaling pathway. Axitinib (AG 013736) is a VEGFR TK inhibitor. Because of the poor prognosis of patients with stage III melanoma and indications that anti-angiogenesis compounds might have clinically meaningful activity in this disease, a Phase 2 trial of the vascular endothelial growth factor receptor tyrosine kinase (VEGFR TK) inhibitor Axitinib (AG 013736) is warranted.

Conditions

• Melanoma
• Malignant Melanoma
• Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma

Interventions

Type	Name	Description
PROCEDURE	therapeutic conventional surgery	Undergo surgery
OTHER	laboratory biomarker analysis	Correlative studies
DRUG	Axitinib	Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events.
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2011-12-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2011-03-23
• Last updated: 2021-01-20
• Results posted: 2021-01-20

Locations

1 site across 1 country: United States