New drug cocktail targets tough cancers in early trial
NCT ID NCT02215720
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 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: * 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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