CompletedPhase 1

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

France19 participantsStarted 2011-03

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * Histologically proven advanced adult solid tumors, with the exception of Hodgkin and non Hodgkin lymphoma. Patients with hepatocellular carcinomas (HCC) may be enrolled without histological documentation if they meet the consensus non-invasive diagnostic criteria. * Failure or contra-indication of all standard therapies, except for the patients with advanced renal cell carcinoma, enrolled at the recommended dose who will be naïve of previous lines of therapy while metastatic. * Age \> 18 years * ECOG Performance status (PS) 0-1 * Life expectancy \> 3 months * Measurable/evaluable disease according to RECIST CRITERIA version 1.0 * Acceptable biological values: Hemoglobin \> 10g /dL; neutrophils \> 1.5 x 109/L; platelets \> 100 x 109/L, AST and ALT \< 2.5 x the upper normal limits (UNL), or \< 5 x UNL in case of liver metastases, GGT \< 3 x the upper normal limits (UNL), PAL \< 2.5 x the upper normal limits (UNL), or \< 5 x UNL in case of liver metastases, serum bilirubin \< 1.5 x ULN, creatinine clearance (Cockroft \& Gault formula) \> 60 mL/min. * 24 hours proteinuria ≤ 1 g/24 h * Albumin \> 30 g/l * Amylase and lipase ≤ 1.5 UNL * Electrolytes (calcium, sodium, potassium, chlore, magnesium, phosphate) in the normal range. Supplementation could be possible before study entry. * Total cholesterol ≤ 2.5 UNL * Triglycerides ≤ 2.5 UNL * BP \< 140/90 * Washout period from last anticancer therapy, including radiation and surgery \> 3 weeks and recovery of toxic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: during cycle 1

Trial details

NCT IDNCT01334073

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Malignant Advanced Solid Tumors trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.