NCT00827359

Biomarker Trial of Everolimus in Patients With Advanced Renal Cell Carcinoma

A Phase II Biomarker Trial of Everolimus in Patients With Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if certain features of tumor specimens sampled prior to therapy can predict for the likelihood of responding to everolimus.

Detailed description

* Participants will undergo a CT or ultrasound guided biopsy of an accessible tumor lesion before beginning the study medication. * Everolimus tablets will be taken orally once a day. Participants will undergo a physical exam and will be asked questions about their general health and specific questions about any problems they might be having. Photographs will be taken of the tumor to assess the response to treatment. This will be done by a CT or MRI scan. Blood tests will be performed every 4 weeks. In addition, blood for research purposes will be done on day 1 of every other cycle. A urine test will be done every 4 weeks.

Conditions

• Renal Cell Carcinoma
• Renal Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	Tablet form taken orally once a day

Timeline

• Start date: 2009-03-01
• Primary completion: 2018-01-01
• Completion: 2018-06-01
• First posted: 2009-01-22
• Last updated: 2021-02-24
• Results posted: 2021-02-24

Locations

3 sites across 1 country: United States