Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma (NCT03839498) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma
United States6 participantsStarted 2019-01-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
Adults with a confirmed pathologic diagnosis of pheochromocytoma/paraganglioma by a CUMC/NYPH laboratory when such tissue is available to confirm.
In the event that outside tissue is not available:
An outside pathology report confirms the diagnosis of Pheo/PGL, AND the patient has nuclear medicine imaging studies that would only be positive in an adult patient with a diagnosis of Pheo/PGL (F-DOPA, Dotatate, F-Dopamine or MIBG)
* Imaging confirmation of metastatic disease
* Measurable disease at the time of enrollment as per RECIST 1.1.
* A life expectancy of at least 3 months and ECOG performance status ≤ 2
* Age ≥ 18 years
* Information available or pending regarding possible genetic alterations that can explain the patient's pheochromocytoma/paraganglioma (mutations in SDHB, SDHV or VHL genes)
* Last dose of chemotherapy or experimental therapy more than 4 weeks (6 weeks in the case of nitrosourea) prior to enrollment date; 2 weeks if the last therapy was received as part of a "phase 0" or "exploratory IND" trial. Last surgery more than 4 weeks prior to enrollment, to allow for wound healing. Core biopsies or FNA will not require any waiting period
* Last radiotherapy treatment ≥ 4 weeks prior to starting treatment with this protocol and there must be sites of measurable disease that did not receive radiation
* Prior therapeutic MIBG is allowed
* Organ and marrow function as defined below:
* Total bilirubin ≤ 1.5 x ULN (upper limit of normal), unless …