Axitinib for Pheochromocytoma/Paraganglioma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use certain drugs that affect liver enzymes (CYP3A4 and CYP1A2) or require certain blood thinners. It's best to discuss your current medications with the trial team to see if any need to be adjusted.
Is axitinib safe for use in humans?
Axitinib, also known as Inlyta, has been generally well tolerated in clinical trials for various conditions, including renal cell carcinoma and neuroendocrine tumors. Common side effects include diarrhea, high blood pressure, fatigue, nausea, and vomiting. However, it can cause serious high blood pressure in some patients, which may require stopping the treatment.12345
How does the drug Axitinib differ from other treatments for pheochromocytoma/paraganglioma?
Axitinib is a tyrosine kinase inhibitor, which targets specific proteins involved in tumor growth and blood vessel formation, making it a novel option for pheochromocytoma/paraganglioma where no standard treatments are approved. This mechanism of action is different from other therapies that may not specifically target these pathways.678910
Who Is on the Research Team?
Antonio Fojo, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
Adults diagnosed with advanced pheochromocytoma/paraganglioma who haven't had surgery, chemotherapy, or radiotherapy in the last 4 weeks (6 for certain drugs). They must have measurable disease, be expected to live at least 3 months, and have an ECOG status ≤2. Pregnant women and those with unstable blood pressure or other severe conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Axitinib therapy for 16 weeks, with clinic visits every 4 weeks to monitor therapy
Follow-up
Participants are monitored for progression-free survival and response rate after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axitinib
Axitinib is already approved in European Union, United States, United Kingdom for the following indications:
- Renal cell carcinoma
- Advanced renal cell carcinoma
- Advanced renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University