NCT01932177

EVESOR: a Phase 1 Trial of Everolimus and Sorafenib

EVESOR: a Phase 1 Trial of Everolimus and Sorafenib to Assess the Impact of Doses and Administration Sequences on Pharmacokinetic and Pharmacodynamic Effects of the Combination

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

EVESOR multiparameter phase I trial aims at determining the safety of different doses and dosing schedules of everolimus in combination with sorafenib as well as the recommended doses \& dosing schedules for phase 2 trials in adult patients with advanced solid tumors.

Detailed description

The present phase I trial aims at determining the safety of different doses and dosing schedules of everolimus in combination with sorafenib as well as the recommended doses \& dosing schedules for phase 2 trials in adult patients with advanced solid tumors.

Conditions

• Metastatic or Locally Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Everolimus and sorafenib	Everolimus will be given alone during a 2 week run-in period before starting sorafenib. Subsequently sorafenib will be administered twice a day while everolimus will be given once a day continuously.
DRUG	Everolimus and sorafenib	Sorafenib will be given alone during a 2 week run-in period before starting everolimus. Subsequently sorafenib will be administered twice a day while everolimus will be given once a day continuously.
DRUG	Everolimus and sorafenib	Bid sorafenib will be given every other week alternating with 1 week qd everolimus. Doses will be escalated.
DRUG	Everolimus and sorafenib	Sorafenib will be given twice a day for 3 days-on 4 days-off while everolimus will be administered continuously on a daily basis. Doses will be escalated.

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-05-01
• Completion: 2015-10-01
• First posted: 2013-08-30
• Last updated: 2013-08-30

Locations

1 site across 1 country: France