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New drug cocktail targets tough cancers in early trial

NCT ID NCT02215720

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This early-phase study tested a combination of two drugs, temsirolimus and cetuximab, in 45 adults with advanced or metastatic solid tumors that had not responded to standard treatments. The goal was to check safety and see if blocking two cancer pathways at once could slow tumor growth. Results are limited to safety and tumor response measurements.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
temsirolimus and cetuximab
What this could lead to
If successful, this could point toward a new combination treatment for advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 45 participants, focused on safety. The combination may not shrink tumors or could cause significant side effects.

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

45 people

The number who actually took part.

Started

Apr 2011

Finished

May 2016

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: * Patients with malignant tumor confirmed histologically or cytologically who does not respond to usual therapeutics or for whom there is no curative treatment * Age \>/= 18 years * ECOG 0 or 1 * Life expectancy \>/= 12 weeks * Grade \</=1 for all adverse effects related to previous therapy or surgery (except for alopecia) * Appropriate organic functions as defined: * ASAT and ALAT \</= 2.5xLSN or ASAT and ALAT \</= 5xLSN in case of inappropriate hepatic function due to the underlying disease * Bilirubin \</= 1.5xLSN * Albumin \>/= 3.0 g/dL * Neutrophil counts (PNN) \>/= 1 500/mL * Platelets \>/= 100 000/mL * Hemoglobin \>/= 9.0 g/dL * Creatinin \</= 1.5xLSN * Cooperative patients able to respect the protocol Exclusion Criteria: * Treatment by chemotherapy, radiotherapy, surgery or the two compounds of the study within 4 weeks before the inclusion * Previous treatment with an association of mTOR inhibitor or EGFR inhibitor * Diagnosis of a secondary cancer within the last 3 years except for a basal-cell carcinoma, cutaneous spinocellular cancer or in situ carcinoma well treated * Grade \>/= 2 nephropathy according to NCI CTCAE * Current treatment with curative dose of coumadin or heparin of low molecular weight * Previous uncontrolled brain metastases, medullar compression or carcinomatosis meningitis or any proof of leptomeningeal pathology or metastasis. * Presence of one og those pathologies during the last 12 months before the inclusion: * myocardial infarction * angina pectoris * bypass of coronal or peripheral arteries * heart failure * stroke * cerebral bleeding * pulmonary embolism * Grade 3 bleeding according to NCI CTCAE criteria less than 3 weeks before treatment start * Uncontrolled high blood pressure (\>150/100mhHg) * Grade \>/=2 heart rate disorder, atrial fibrillation whichever the grade, lengthen of QTC \>450 msec for male or \>470 msec for female. * Patients HIV positive * Pregnant or breastfeeding woman * Patients with psychiatric disorder * Active alcoholism * Previous pulmonary interstitial disease * Previous hypersensitivity to antihistamine treatment and/or medical contraindication for an antihistamine or corticoid treatment

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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

  • Gustave Roussy

    Villejuif, Val de Marne, 94805, France

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