NCT02352844

Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations

Phase II Study of Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to look at participants with solid tumor malignancies and specific mutations respond to treatment with everolimus.

Detailed description

Cancer is a molecularly heterogeneous disease comprised of complex genomic alterations in common and overlapping pathways. Somatic inactivating mutations in tuberous sclerosis complex 1 (TSC1) gene were recently identified as potential markers of response to mTOR therapy. Everolimus is an oral derivative of rapamycin. At the cellular and molecular level, everolimus acts as a signal transduction inhibitor, and selectively inhibits mTOR. We hypothesize that everolimus will exhibit clinical activity in solid malignancies harboring TSC1, TSC2, NF1, NF2, or STK11 mutations.

Conditions

• Solid Malignancy
• Solid Tumor

Interventions

Type	Name	Description
DRUG	Everolimus

Timeline

• Start date: 2015-10-07
• Primary completion: 2017-08-15
• Completion: 2017-08-15
• First posted: 2015-02-02
• Last updated: 2018-10-02
• Results posted: 2018-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study