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NCT01334073
PHASE1

Study of the Combination of Axitinib Plus Everolimus in Patients With Malignant Advanced Solid Tumors

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

The aim of the study is to determine the MTD of the combination of everolimus plus axitinib in solid tumors, especially RCC.

Official title: Phase I Study of the Combination of Axitinib (AX) Plus Everolimus (EV) in Patients With Malignant Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2011-03

Completion Date

2015-01

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

Axitinib plus everolimus

Patients will take both drugs orally, every day, without planned rest period (AX bid and EV once a day). By convention one cycle is 28 days. At the first cycle patients will take one week of AX single agent before starting EV. Patients will be treated at increasing dose levels (DLs) in successive cohorts of 3-6 patients according to the number of patients with dose limiting toxicities (DLT) until the maximum tolerated dose

Locations (2)

Professeur Alain RAVAUD

Bordeaux, France

Professeur Jean-Pierre DELORD

Toulouse, France