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
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|ClinicalTrials.gov Identifier: NCT01582191|
Recruitment Status : Recruiting
First Posted : April 20, 2012
Last Update Posted : July 3, 2018
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.
This is an investigational study. Vandetanib is FDA-approved and commercially available for the treatment of medullary thyroid carcinoma. Everolimus is FDA-approved and commercially available for the treatment of pancreatic neuroendocrine tumor, subependymal giant cell astrocytoma, and renal cell carcinoma. The use of these drugs in combination for the treatment of advanced cancer is investigational.
Up to 174 patients will take part in this multicenter study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancers||Drug: Vandetanib Drug: Everolimus||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||174 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2026|
|Estimated Study Completion Date :||May 2026|
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.
Starting Dose: 100 mg by mouth daily in a 28 day cycle.
Starting dose: 2.5 mg by mouth daily of a 28 day cycle.
- 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).
- Tumor Response [ Time Frame: 6 months ]
Tumor response defined as one or more of the following:
- stable disease for more than or equal to 6 months,
- decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria,
- decrease in tumor markers by more than or equal to 25% (for example, a >/= 25% decrease in CA125 for patients with ovarian cancer), or
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582191
|Contact: Vivek Subbiah, MD||713-563-0393|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vivek Subbiah, MD||M.D. Anderson Cancer Center|