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

NCT01334073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-05-14

No results posted yet for this study

Summary

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

Conditions

  • Malignant Advanced Solid Tumors
  • Carcinoma, Renal Cell

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

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Alain RAVAUD · University Hospital, Bordeaux

  • Adélaïde Doussau, Dr · University Hospital, Bordeaux

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-05-31
Completion
2015-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01334073 on ClinicalTrials.gov