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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 study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: April 18, 2012
Last updated: August 10, 2016
Last verified: August 2016

The goal of this clinical research study is to find the highest tolerable dose of the combination of vandetanib and everolimus that can be given to patients with advanced cancer. The effects of the study drugs at different dose levels and the safety of the study drugs will also be studied.

Vandetanib and everolimus are both designed to harm cancer cells, stopping their growth. This may stop or slow the growth or spread of cancer cells.

Condition Intervention Phase
Advanced Cancers
Drug: Vandetanib
Drug: Everolimus
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Vandetanib with Everolimus [ Time Frame: 28 days ]
    Maximum tolerated dose (MTD) defined as highest dose studied in which incidence of dose limiting toxicity (DLT) less than 33%. MTD defined by DLTs that occur in first 28-day cycle (induction phase).

Secondary Outcome Measures:
  • Tumor Response [ Time Frame: 6 months ]

    Tumor response defined as one or more of the following:

    1. stable disease for more than or equal to 6 months,
    2. decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria,
    3. decrease in tumor markers by more than or equal to 25% (for example, a >/= 25% decrease in CA125 for patients with ovarian cancer), or
    4. a partial response according to the Choi criteria, i.e. decrease in size by 10% or more, or a decrease in the tumor density by 15% or more

Estimated Enrollment: 174
Study Start Date: May 2012
Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vandetanib + Everolimus

Starting dose of Vandetanib: 100 mg by mouth daily in a 28 day cycle.

Starting dose of Everolimus: 2.5 mg by mouth daily in a 28 day cycle.

Drug: Vandetanib
Starting Dose: 100 mg by mouth daily in a 28 day cycle.
Other Names:
  • ZD 6474
  • Zactima
  • Caprelsa
Drug: Everolimus
Starting dose: 2.5 mg by mouth daily of a 28 day cycle.
Other Names:
  • Afinitor
  • RAD001

  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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.
  3. ECOG performance status should be less or equal to 3
  4. 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.
  5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence).

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
  2. Pregnant or lactating women.
  3. History of hypersensitivity to vandetanib, lactose, murine products, or any component of the formulation.
  4. History of hypersensitivity to sirolimus, temsirolimus, everolimus.
  5. History of hypersensitivity to any component of the formulation.
  6. Patients unwilling or unable to sign informed consent document.
  7. Presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
  8. History (within the last 3 months) or presence of stroke/cerebrovascular accident.
  9. Congenital long QT syndrome.
  10. QTcF interval greater than 500 ms that is not correctable to less than 500ms such as with cessation of a causative medication, etc.
  11. History of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
  12. Presence of a symptomatic bradyarrhythmia or uncompensated heart failure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01582191

Contact: Vivek Subbiah, MD 713-563-0393

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Vivek Subbiah, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01582191     History of Changes
Other Study ID Numbers: 2011-0953
NCI-2012-00782 ( Registry Identifier: NCI CTRP )
Study First Received: April 18, 2012
Last Updated: August 10, 2016

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Advanced solid cancer
Metastatic cancer
ZD 6474
Multi-kinase Inhibitor

Additional relevant MeSH terms:
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on May 23, 2017