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Spots Global Cancer Trial Database for Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer

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Trial Identification

Brief Title: Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer

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

Study ID: NCT01582191

Study Description

Brief Summary: 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.

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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

M D Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Sarina Piha-Paul, MD

Affiliation: M.D. Anderson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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