New drug combo shows promise in halting advanced cancers
NCT ID NCT01582191
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This early-phase trial tested a combination of two drugs, vandetanib and everolimus, in 151 people with advanced or metastatic cancer that had stopped responding to standard treatments. The goal was to find the safest dose and see if the combination could slow or stop cancer growth by blocking key enzymes. The study focused on side effects and tumor response, not on curing the disease.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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123 people
The number who actually took part.
- Started
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May 2012
- Finished
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Oct 2025
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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 advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months. * Patients must be at least 3 weeks beyond their previous cytotoxic chemotherapy. * Patient must be at least 5 half-lives or 3 weeks, whichever is shorter, from their previous targeted or biologic therapy; In addition, patients must be at least 3 weeks beyond the last session of radiation therapy. Local palliative radiation therapy that is not delivered to all target lesions is allowed immediately before or during treatment. * ECOG performance status should be less or equal to 3 * Patients must have organ and marrow function defined as: Absolute neutrophil count more or equal to 750/mL; platelets more or equal to 50,000/mL; creatinine less or equal to 3x ULN; total bilirubin less than or equal to 3.0. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence). Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support. * Pregnant or lactating women. * History of hypersensitivity to vandetanib, lactose, murine products, or any component of the formulation. * History of hypersensitivity to sirolimus, temsirolimus, everolimus. * History of hypersensitivity to any component of the formulation. * Patients unwilling or unable to sign informed consent document. * Presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia. * History (within the last 3 months) or presence of stroke/cerebrovascular accident. * Congenital long QT syndrome. * QTcF interval greater than 500 ms that is not correctable to less than 500ms such as with cessation of a causative medication, etc. * History of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the Investigator, increases the risk of ventricular arrhythmia. * Presence of a symptomatic bradyarrhthmia or uncompensated heart failure.
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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
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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