Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer
August 7, 2026 updated by: M.D. Anderson Cancer Center
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) or highest dose level, and the dose-limiting toxicity (DLT) of vandetanib (a multi-kinase inhibitor of epidermal growth factor receptor [EGFR], vascular endothelial growth factor receptor [VEGFR] and ret proto-oncogene [RET] inhibitor) when used in combination with everolimus (a mammalian target of rapamycin [mTOR] inhibitor) in advanced cancer.
II. Preliminary descriptive assessment of the anti-tumor efficacy of the combination.
III. Preliminary optional assessment of the pharmacokinetic, pharmacodynamic markers of target inhibition and correlates of response.
OUTLINE: This is a dose-escalation study.
Patients receive vandetanib orally (PO) once daily (QD) and everolimus PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment patients are followed up between 14-28 days at the discretion of the treating physician.
Study Type
Interventional
Enrollment (Actual)
123
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment (vandetanib, everolimus)
Patients receive vandetanib PO QD and everolimus PO QD on days 1-28.
Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Given PO
Other Names:
Optional correlative studies
Optional correlative studies
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT)
Time Frame: First 28-day cycle
|
DLT is defined as any clinically significant grade 3 or 4 non-hematologic toxicity as defined in the NCI-CTCAE v3.0, expected and believed to be related to the study medications, any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE) or associated with bleeding and/or sepsis; Grade 3 to 4 thrombocytopenia lasting 7 days or thrombocytopenia associated with active bleeding or requiring platelet transfusion; Grade 3 nausea/vomiting lasting > 48 hours or any Grade 4 nausea/vomiting despite maximum anti-nausea regimens (i.e.
excluding Grade 3 nausea or Grade 3 to 4 vomiting or diarrhea in patients who had not received optimal antiemetic and anti-diarrheal treatment); and any other clinically significant Grade 3 non-hematologic toxicity including symptoms or signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complications or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.
|
First 28-day cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarina Piha-Paul, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2012
Primary Completion (Actual)
October 22, 2025
Study Completion (Actual)
October 22, 2025
Study Registration Dates
First Submitted
April 18, 2012
First Submitted That Met QC Criteria
April 19, 2012
First Posted (Estimated)
April 20, 2012
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 7, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-0953 (Other Identifier: M D Anderson Cancer Center)
- NCI-2012-00782 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 0953
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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