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Tyrosine Kinase Inhibitor
Axitinib for Pheochromocytoma/Paraganglioma
Phase 2
Recruiting
Led By Antonio Fojo, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of time from start of treatment to time of progression or death, whichever occurs first; an average of up to 12 months
Awards & highlights
Study Summary
This trial is testing a daily dose of axitinib to see if it can treat pheochromocytoma or paraganglioma.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing Axitinib's effectiveness on metastatic or locally advanced pheochromocytoma/paraganglioma. It aims to see how well patients respond to daily treatment, measure how long they live without the disease getting worse, and explore genetic factors related to drug metabolism.See study design
What are the potential side effects?
Axitinib may cause high blood pressure, fatigue, nausea, diarrhea, decreased appetite and weight loss. Rare but serious side effects include bleeding problems and heart issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of time from start of treatment to time of progression or death, whichever occurs first; an average of up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of time from start of treatment to time of progression or death, whichever occurs first; an average of up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate (RR)
Secondary outcome measures
Progression-free survival
Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT0212964730%
Mucositis
10%
Fatigue
10%
Rash
10%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axitinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Axitinib (AG-013736)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axitinib
FDA approved
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,808 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,849 Total Patients Enrolled
1 Trials studying Pheochromocytoma
25 Patients Enrolled for Pheochromocytoma
Antonio Fojo, MD3.45 ReviewsPrincipal Investigator - Columbia University
Columbia University
1 Previous Clinical Trials
1Patient Review
I would recommend finding another physician who is more knowledgable. There are plenty of other great options in New York City.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tumors that can be completely removed with surgery.Patients with large masses in their abdomen or lungs that could cause bleeding will be evaluated individually after consulting with different medical experts.Your blood pressure is consistently high despite taking medicine for it.You have signs of a blood clotting problem.You have not received treatment for brain metastases in the past 3 months.You have another type of cancer, except for certain types of skin or cervical cancer.Adults with a confirmed diagnosis of pheochromocytoma/paraganglioma by a specific laboratory test.Your doctor has confirmed that the cancer has spread to other parts of your body using imaging tests.Your organs and bone marrow need to be working properly within certain limits.You have been diagnosed with Pheo/PGL, and specific imaging tests show signs of this condition in adults.Previous treatment with MIBG is acceptable.You have received treatment with a specific type of medication called a TKI before.You have any issues with your stomach or intestines.You are taking or will need to take medications that strongly affect how the body processes other drugs.You have a serious medical or mental health condition that could make participating in the study risky.You are taking medication to prevent blood clots that is in the form of a pill.You currently have seizures or signs of cancer spread to the brain or spinal cord.You have a history of certain heart and medical problems.You have a detectable disease at the time of joining the study according to specific guidelines.You are expected to live for at least 3 more months and are able to perform daily activities with a little help.You have genetic mutations in specific genes that may be causing your pheochromocytoma/paraganglioma.
Research Study Groups:
This trial has the following groups:- Group 1: Axitinib (AG-013736)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the latest findings regarding Axitinib's safety and efficacy?
"Axitinib receives a score of 2 in terms of safety. This is due to the lack of efficacy data, as this medication is still in Phase 2 clinical trials."
Answered by AI
Has Axitinib been studied in a clinical setting before?
"Axitinib is being studied in 50 different clinical trials, 4 of which are in Phase 3. The majority of Axitinib studies are taking place in Houston, Texas; however, there are 1,032 total trial locations."
Answered by AI
Are there any current openings in this clinical trial for new patients?
"The trial, which has been updated as recently as October 5th, 2022, is looking for participants and is posted on clinicaltrials.gov"
Answered by AI
How novel is this clinical trial's design?
"Axitinib has undergone 50 clinical trials since 2011, with the most recent ones taking place in 385 cities across 30 countries."
Answered by AI
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