Trials / Completed
CompletedNCT01582191
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Advanced Malignant Neoplasm
- Metastatic Malignant Neoplasm
- Recurrent Malignant Neoplasm
- Refractory Malignant Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Everolimus | Given PO |
| OTHER | Laboratory Biomarker Analysis | Optional correlative studies |
| OTHER | Pharmacological Study | Optional correlative studies |
| DRUG | Vandetanib | Given PO |
Timeline
- Start date
- 2012-05-14
- Primary completion
- 2025-10-22
- Completion
- 2025-10-22
- First posted
- 2012-04-20
- Last updated
- 2025-10-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01582191. Inclusion in this directory is not an endorsement.