SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Phase 2 Completed 52 enrolled Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center · collab Massachusetts General Hospital · collab Pfizer · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate how effective Sunitinib works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.

Timeline

Start: 2007-08
Primary completion: 2014-08
Completion: 2014-08

Outcome

Met primary endpoint

paper proportion of patients alive and progression-free at 2 months was 52% (95% confidence interval, 38%-66%); this was significantly larger than the hypothesized null of 5%. PMID 26264378 ↗

Publications

Results Buchbinder EI, Sosman JA, Lawrence DP, McDermott DF, Ramaiya NH, Van den Abbeele AD, Linette GP, Giobbie-Hurder A, Hodi FS. Phase 2 study of sunitinib in patients with metastatic mucosal or acral melanoma. Cancer. 2015 Nov 15;121(22):4007-15. doi: 10.1002/cncr.29622. Epub 2015 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sunitinib	Small molecule	37.5 mg	Oral
Subject	Sunitinib	Small molecule	50 mg	Oral