NCT01582191CompletedPhase 1
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer
A Phase 1 Trial of Vandetanib (a Multi-Kinase Inhibitor of EGFR, VEGFR, and RET Inhibitor) in Combination With Everolimus (an mTOR Inhibitor) in Advanced Cancer
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
This phase I trial studies the side effects and best dose of vandetanib and everolimus when given together in treating patients with cancer that has spread to other places in the body. Vandetanib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 123 (actual)
- First submitted
- 18 Apr 2012
- Start date
- 14 May 2012
- Primary completion date
- 22 Oct 2025
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT01582191
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 123
- From 14 May 2012 to the primary completion date, 22 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- QTcF interval greater than 500 ms that is not correctable to less than 500ms such as with cessation of a causative medication, etc.
Other illness
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- 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.
- 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.
- 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.
Lab values
- Congenital long QT syndrome.
Other
- Pregnant or lactating women.
- Patients unwilling or unable to sign informed consent document.
Who the study is looking for
- 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).
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.