drugset / Trial / NCT03839498
Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: To determine the response rate (RR) of metastatic or locally advanced pheochromocytoma/paraganglioma to axitinib administered daily. Secondary Objectives: * Determine the progression-free survival. * In an exploratory manner examine the extent of activation of the VEGFR pathway in pheochromocytoma/paraganglioma using a semi-quantitative immunohistochemistry assay and examine the relationship with response to therapy. * Perform pharmacogenomics analyses of drug metabolism and transport proteins through germline DNA examination.
Timeline
- Start
- 2019-01-22
- Primary completion
- 2027-01
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axitinib | Small molecule | 2 mg | Oral |
| Subject | Axitinib | Small molecule | 3 mg | Oral |
| Subject | Axitinib | Small molecule | 5 mg | Oral |
| Subject | Axitinib | Small molecule | 7 mg | Oral |
| Subject | Axitinib | Small molecule | 10 mg | Oral |