A Phase 1 interventional study of Axitinib plus everolimus in Malignant Advanced Solid Tumors and Carcinoma, Renal Cell, sponsored by University Hospital, Bordeaux. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Bordeaux · Phase 1, Interventional, and Treatment
The aim of the study is to determine the MTD of the combination of everolimus plus axitinib in solid tumors, especially RCC.
Phase I study of the combination of axitinib (AX) plus everolimus (EV) in patients with malignant advanced solid tumors.
Phase I, multicentre, open-label, non-randomized, sequential algorithm based dose-finding (3+3), clinical study in successive cohorts of patients.
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 (MTD; i.e. the DL at which \<= 1/6 patient experiences a DLT during the first cycle). All decision concerning qualification for DLT, dose escalation, study termination, inclusion of additional patients, will be taken by a Trial Monitoring Committee..
The MTD will not be higher than the recommended dose of each single agent. Six additional patients will be entered at the MTD to confirm the feasibility of the dose and preliminarily assess the efficacy of the combination in patients with RCC untreated with antiangiogenics.
Three levels of dose will be explored.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 377 are open to participants now.
This study's enrollment of 19 is below the median of 42 across 1,479 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
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
Proportion of patients with DLT (dose limiting toxicity) during the first cycle (first 28 days of the combination of both study compounds), per dose level explored
A DLT will be one of the following adverse events, with a possible relationship to the study medications * Febrile, related bleeding or any grade 4 neutropenia or thrombocytopenia, * grade 3 non-hematological toxicity, unless adequately treated with usual symptomatic therapy * grade 4 non-hematological toxicity * study treatment interruption \> 2 weeks, inability to deliver at least 80% of the intended doses of axitinib and/or everolimus between day 8 and 35 due to toxicity.
Time frame: during cycle 1
Adverse event (AE) will be graded according to NCI-CTC criteria V3
Number of AE per patient, per grade, per cycle and per dose level, proportion
Time frame: After each cycle of treatement
Best response rate will be assessed according to RECIST criteria, during the follow-up
Frequency (total, per dose level), proportion
Time frame: Every other cycle of treatment
Rate of non-tumor progression at 16 weeks
Frequency (total, per dose level), proportion
Time frame: at 16 weeks
Progression-free Survival (PFS) defined as the time between study treatment initiation and either tumor progression or death, regardless of the cause, whichever occurs first and PFS at 1 year
Frequency (total, per dose level), probability
Time frame: 1 year
Comparison of PK parameters
Plasma PK using peak concentration (Cmax), area under the concentration versus time curve (AUC), volume of distribution at steady state (Vdss), plasma clearance (CL) and plasma half-life (t1/2). PK parameters will be compared to severe (grade 3-4) AEs, tumor responses and non-tumor progression at 16 weeks. PK parameters of axitinib combined to everolimus (day 15) will be compared to PK parameters of axitinib alone in the same patient (day 1). PK of everolimus combined to axitinib (day 15) will be compared to historical data of everolimus alone
Time frame: day 1 (axitinib alone) and day 15 (everolimus combined with axitinib)
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux