New drug cocktail aims to fight advanced cancers
NCT ID NCT01334073
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a daily combination of two oral drugs, axitinib and everolimus, in 19 people with advanced solid tumors, particularly kidney cancer. The main goal was to find the safest dose by monitoring side effects in the first month. Researchers also tracked how well the tumors responded to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- axitinib plus everolimus (two oral drugs taken daily)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced solid tumors, especially kidney cancer, by shrinking tumors or slowing their growth.
- What could go wrong
- This is a very early Phase 1 trial with only 19 participants, focused on finding a safe dose. The combination may cause significant side effects and may not prove effective in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
19 people
The number who actually took part.
- Start date
-
Mar 2011
- Finished
-
Jan 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 toxicities to NCI-CTC grade \< 1. * Written informed Consent. * Use of effective contraceptive method (Intrauterine device, oral combined contraceptive) for women of child-bearing age or whose partner is included in the trial. * Patient with french social security. * Additional inclusion criteria before the association axitinib plus everolimus period * No toxicity with NCI-CTC grade \> 2 at the end of axitinib alone period just before starting axitinib and everolimus (cycle 1) * BP \< 140/ 90 Exclusion criteria * Brain metastasis * Severe underlying cardiovascular disease, even medically controlled, such as angina pectoris, myocardial infarction, cardiac insufficiency, cardiac failure, cerebral strokes, lower limb ischemic disease, thromboembolic disease, and any patient, who, in the investigator's opinion is at high risk for arterial or venous thromboembolism. * Hepatitis B or C carrier or at a chronic state * Uncontrolled hypertension, or diabetes mellitus despite medical treatment. * Inability to swallow pills * Unresolved pneumopathy, no need for antibiotherapy * Any medical or social condition, which; in the investigator's opinion, would jeopardize patient's safety, patient's compliance to the protocol, or the interpretation of study results. These conditions include (but are not limited to): severe infection, cardiac failure, chronic gastrointestinal disease compromising oral drug absorption, psychiatric illnesses, foreseeable poor treatment compliance with oral medications, patients living far away from the investigational centers, etc… * Hypersensitivity to Axitinib or Everolimus * Participation to another clinical trial, or use of an unapproved medication within 4 weeks prior to study treatment initiation. * Pregnant or lactating women.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Professeur Alain RAVAUD
Bordeaux, 33000, France
-
Professeur Jean-Pierre DELORD
Toulouse, 31000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Can turbocharged immune cells stop liver cancer from coming back?
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers