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Neoadjuvant Cabozantinib for Kidney Cancer
Phase 2
Waitlist Available
Led By Mehmet Asim Bilen, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of childbearing potential must not be pregnant at screening and must meet specific criteria
No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy in the 5 years prior to current study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of surgery to death from any cause, assessed up to 3 years
Awards & highlights
Study Summary
This trial will study how well cabozantinib works in treating patients with kidney cancer before surgery. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults with advanced kidney cancer that hasn't spread elsewhere. They should be fit enough for daily activities (ECOG ≤ 1), have good organ function, and not have had cancer treatment in the last 5 years. Participants must agree to use contraception and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests Cabozantinib's effectiveness when given before surgery to patients with locally advanced kidney cancer. It aims to see if this drug can halt tumor growth by blocking enzymes needed for cell proliferation.See study design
What are the potential side effects?
Cabozantinib may cause side effects like fatigue, high blood pressure, nausea, diarrhea, decreased appetite, hand-foot syndrome (redness and pain in hands/feet), weight loss, vomiting, changes in hair color or voice.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and meet the specific criteria for women of childbearing age.
Select...
I haven't had cancer treatment like hormonal, chemotherapy, or immunotherapy in the last 5 years.
Select...
My kidney cancer biopsy shows clear cell features.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My blood tests show my organs and bone marrow are working well.
Select...
My kidney tumor is large or has spread, making surgery not an option.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of surgery to death from any cause, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of surgery to death from any cause, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Disease-free survival (DFS)
Frailty assessment
Overall survival (OS)
+2 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
DIZZINESS
14%
BILIRUBIN INCREASED
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
RASH
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
SINUS BRADYCARDIA
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hoarseness
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Stomach Pain
5%
TENDONITIS
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib)Experimental Treatment1 Intervention
Patients receive cabozantinib orally once daily for 12 weeks in the absence of disease progression or unacceptable toxicity. The assigned starting dose for cabozantinib is 60 mg/day. Two dose reduction levels of cabozantinib are permitted
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,554 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,532 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,560 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and meet the specific criteria for women of childbearing age.There is proof of cancer spreading to other parts of the body on the images taken before starting the treatment.I haven't had major surgery recently.I haven't had cancer treatment like hormonal, chemotherapy, or immunotherapy in the last 5 years.I have received treatments like chemotherapy for kidney cancer.I haven't had another cancer diagnosis in the last 2 years, with some exceptions.My kidney cancer biopsy shows clear cell features.My liver function is significantly impaired.I cannot swallow pills.I am fully active and can carry on all my pre-disease activities without restriction.I do not have any severe ongoing illnesses like heart or stomach problems.Your blood clotting tests show abnormal results within 14 days before starting the study treatment.I have symptoms of underactive thyroid that aren't treated.I have a serious wound, ulcer, or bone fracture that isn't healing.My heart's electrical activity, measured by ECG, is within normal limits.My blood tests show my organs and bone marrow are working well.I am currently taking blood thinners or platelet inhibitors.My kidney tumor is large or has spread, making surgery not an option.I have cancer that has spread to my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cabozantinib)
Awards:
This trial has 1 awards, including:- 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.
In what instances is cabozantinib typically prescribed?
"Cabozantinib has proven effective at treating advanced renal cell carcinoma, adrenal medulla cancer, and other malignancies that have resisted anti-vegf treatment."
Answered by AI
How many volunteers have enrolled in the experiment thus far?
"Sadly, this study is not currently recruiting. It was posted on the 6th of August 2019 and last updated on 28th June 2022. However, 2582 medical studies for renal cell carcinoma are presently accepting participants as well as 109 trials involving Cabozantinib therapy."
Answered by AI
Has the FDA sanctioned Cabozantinib for therapeutic use?
"Data illustrating the safety of cabozantinib is available, leading to a score of 2 on our team's scale. As this is Phase 2 clinical trial however, there currently isn't any proof that it can effectively treat diseases or disorders."
Answered by AI
Does this trial present a pioneering approach to research?
"Currently, 109 live trials involving cabozantinib are taking place across 45 nations and 1315 cities. The initial research was conducted in 2012 by Exelixis with a cohort of 86 patients; the Phase 2 drug approval stage has been completed for this study, along with 55 other investigations since then."
Answered by AI
Could you provide an overview of any prior research centered on Cabozantinib?
"Currently, there are 109 studies exploring the potential of cabozantinib. Of these trials, 11 have reached Phase 3 clinical testing. Although Cordoba and Calabria lead in research for this drug, 6849 other sites participate in its evaluation too."
Answered by AI
Are there any opportunities for participants to join this clinical experiment?
"At present, the trial is not actively recruiting. It went online on August 6th 2019 and was last updated June 28th 2022. To those interested in seeking alternative medical trials, there are currently 2582 studies relating to renal cell carcinoma that are open for recruitment as well as 109 listings involving cabozantinib."
Answered by AI
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