← Back to Search

Tyrosine Kinase Inhibitor

Cabozantinib for Prostate Cancer

Phase 2
Recruiting
Led By David M Nanus, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years
Evidence of amplification or activating mutation of selected targets of cabozantinib (including MET, KIT, RET, VEGFR-1, VEGFR-2, VEGFR-3, FLT3, AXL, TRKB, or TIE2) by at least one of the following: DNA sequencing of metastatic tumor biopsy specimen or cfDNA test, RNA sequencing of metastatic tumor biopsy specimen, Commercial cell-free DNA assay, Overexpression by IHC on metastatic tumor biopsy specimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be collected at the time of visit 1 through end of study or 100 months
Awards & highlights

Study Summary

This trial will look at the effects of cabozantinib on a molecularly-selected group of patients with CRPC.

Who is the study for?
This trial is for adults over 18 with metastatic castrate resistant prostate cancer (mCRPC) that's progressing. They must have a certain level of organ function, agree to biopsies, and not have had specific treatments recently. Participants need evidence of gene changes targeted by cabozantinib and must use contraception if fertile.Check my eligibility
What is being tested?
The study tests the effects of cabozantinib on mCRPC patients selected based on molecular criteria like gene amplification or mutations. It aims to see if this drug can shrink tumors or slow their growth in these specifically chosen patients.See study design
What are the potential side effects?
While not explicitly listed here, common side effects from drugs like cabozantinib may include nausea, fatigue, high blood pressure, hand-foot syndrome (redness and pain in hands/feet), diarrhea, decreased appetite, weight loss and possibly liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.
Select...
My cancer has specific genetic changes targeted by cabozantinib.
Select...
I have been diagnosed with prostate cancer through a biopsy.
Select...
I am fully active or can carry out light work.
Select...
I agree to have a biopsy of my cancer before starting treatment.
Select...
My scans show that my prostate cancer has spread.
Select...
My prostate cancer is worsening, shown by tests or scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be collected at the time of visit 1 through end of study or 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be collected at the time of visit 1 through end of study or 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in radiographically progression-free survival following treatment with Cabozantinib radiographically progression-free after 6 months
Secondary outcome measures
Change in adverse event rate response rate
Change in overall survival (OS)
Change in prostate specific antigen (PSA)
+2 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
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%
BILIRUBIN INCREASED
14%
DIZZINESS
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%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
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%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
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%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
5%
RASH
5%
Hoarseness
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: Cabozantinib ArmExperimental Treatment1 Intervention
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?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,279 Total Patients Enrolled
48 Trials studying Prostate Cancer
35,609 Patients Enrolled for Prostate Cancer
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,521 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,266 Patients Enrolled for Prostate Cancer
David M Nanus, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04631744 — Phase 2
Prostate Cancer Research Study Groups: Cabozantinib Arm
Prostate Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04631744 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04631744 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do elderly patients qualify for this test program?

"This study is accepting patients that are between 18-99 years old."

Answered by AI

Are there any other treatment methods that have been trialed using Cabozantinib?

"Memorial Sloan Kettering Commack first researched cabozantinib in 2012 and, to date, 55 clinical trials have completed while 116 more are ongoing. A large portion of these active studies take place in Detroit, Michigan."

Answered by AI

Has there been research like this before?

"Clinical trials for Cabozantinib began in 2012, with Exelixis sponsoring the first study. This initial trial only involved 86 patients. However, after receiving Phase 2 drug approval, there are now 116 active trials taking place across the globe."

Answered by AI

Are there any available openings for volunteers in this clinical research project?

"It is correct that this clinical trial, which was originally advertised on March 3rd 2021, is still seeking patients. This information comes from the website clinicaltrials.gov."

Answered by AI

Which type of patient is this research most applicable to?

"Eligible participants for this study must have a diagnosis of prostate cancer and be between 18 to 99 years old. A maximum of 30 patients will be enrolled in the trial."

Answered by AI

What are the primary conditions that Cabozantinib is used to manage?

"Patients that have undergone anti-vegf treatment in the past are often given Cabozantinib, which has also been shown to be effective against other conditions like advanced renal cell carcinoma (arcc), adrenal medulla, and high risk patients."

Answered by AI

Do people who take Cabozantinib experience many side effects?

"Cabozantinib has not been proven effective yet, but there is some data indicating that it is safe. Therefore, it received a safety score of 2."

Answered by AI

How many people have been recruited for this trial?

"This study necessitates 30 individuals that meet the prerequisites. These patients can come from various places, such as Karmanos Cancer Institute in Detroit, Michigan and Weill Cornell Medicine in New york, New York."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
2021. "Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04631744.
All > Prostate Cancer Boston
~1 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top