A Phase 2, Open-Label, Multi-Center Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer Subjects Who Have Not Responded to Standard Treatment or Relapsed After Standard Treatment
Amuvatinib is an oral multi-targeted tyrosine kinase inhibitor which inhibits the mutant
forms of c-Kit and PDGFR alpha. It also disrupts DNA repair likely through suppression of
Homologous Recombination protein Rad51. In a Phase 1b clinical study in combination with
VP-16 and carboplatin, responses in SCLC were observed. In vitro and in vivo data
demonstrated amuvatinib synergy with VP-16 thereby further supporting this combination for
continued evaluation in clinical trials. Pharmacokinetic data from Phase 1 clinical trials
suggest that co-administration of amuvatinib did not alter exposures of standard of care
agents VP-16 or carboplatin as measured by overall exposure.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall objective response rate (CR or PR)
3 months
No
United States: Food and Drug Administration
SGI-0470-07
NCT01357395
May 2011
May 2013
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Associates in Oncology and Hematology | Chattanooga, Tennessee 37404 |
James Graham Brown Cancer Center, University of Louisville | Louisville, Kentucky 40202 |
Vanderbilt - Ingram Cancer Center | Nashville, Tennessee 37232 |