NCT01014351

Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

A Phase II Study of Everolimus in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle
DRUG	Carboplatin	Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle
DRUG	Everolimus	Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2013-08-01
• First posted: 2009-11-17
• Last updated: 2014-03-26
• Results posted: 2014-03-26

Locations

12 sites across 1 country: United States