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New drug cocktail aims to fight advanced cancers

NCT ID NCT01334073

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.