Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma
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|ClinicalTrials.gov Identifier: NCT03839498|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : May 10, 2019
To determine the response rate (RR) of metastatic or locally advanced pheochromocytoma/paraganglioma to axitinib administered daily.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Pheochromocytoma Paraganglioma||Drug: Axitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma|
|Actual Study Start Date :||January 22, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2024|
Experimental: Axitinib (AG-013736)
Subjects with Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma will receive 16 weeks of therapy (Axitinib), and be seen in clinic every 4 weeks to monitor therapy.
Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.
Starting dose level 1: 5 mg every morning; 5 mg every evening. Dose level 2: 7 mg every morning; 7 mg every evening. Dose level 3: 10 mg every morning; 10 mg every evening. Dose level -1: 3 mg every morning; 3 every evening. Dose level -2: 2 mg every morning; 2 mg every evening.
Axitinib is supplied as 1 and 5-mg tablets and is administered orally twice a day with or without food, each morning and evening (i.e., every 12 hours). Axitinib will be given as self-administered.
Other Name: AG-013736
- Response Rate (RR) [ Time Frame: Up to 16 weeks ]This study is designed to determine the percentage of patients whose cancer shrinks or disappears after treatment.
- Progression-free survival [ Time Frame: Duration of time from start of treatment to time of progression or death, whichever occurs first; an average of up to 12 months ]The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
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): NCT03839498
|Contact: Lisa Olmos, RN||(212) firstname.lastname@example.org|
|Contact: Alexandria Rodriguezemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10031|
|Contact: Antonio Fojo, MD, PhD 212-305-5098|
|Principal Investigator: Antonio Fojo, MD, PhD|
|Principal Investigator:||Antonio Fojo, MD||Columbia University|