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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
Must not have
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders, Gastrointestinal (GI) disorders, Clinically significant hematuria, hematemesis, or hemoptysis, Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation, Lesions invading or encasing any major blood vessels
Subject has received abiraterone acetate or enzalutamide within 2 weeks before enrollment
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
No Placebo-Only Group

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.
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.
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
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I am older than 18 years.
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My cancer has specific genetic changes targeted by cabozantinib.
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I have been diagnosed with prostate cancer through a biopsy.
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I am fully active or can carry out light work.
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I agree to have a biopsy of my cancer before starting treatment.
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My scans show that my prostate cancer has spread.
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My prostate cancer is worsening, shown by tests or scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major ongoing health issues like heart or stomach problems, or serious bleeding.
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I have taken abiraterone acetate or enzalutamide within the last 2 weeks.
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My heart's electrical activity (QTcF) is not over 500 ms.
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I cannot swallow pills.
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I am currently taking blood thinners or platelet inhibitors.
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My tumor shows changes in specific genes like MET or KIT.
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I have been treated with cabozantinib before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in radiographically progression-free survival following treatment with Cabozantinib radiographically progression-free after 6 months
Secondary study objectives
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%
Neutrophil Count Decreased
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
HYPERTENSION
36%
HEADACHE
36%
PAIN IN EXTREMITY
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
Decreased Platelet Count
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Platelet Count Decreased
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
HYPERGLYCEMIA
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
Pruritis
14%
HYPOGLYCEMIA
14%
Rash Acneiform
14%
Rash Maculopapular
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
CONSTIPATION
14%
Fever
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
NASAL CONGESTION
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
Paresthesia
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Hypotension
5%
Joint Range Of Motion Decreased
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Muscle Weakness Upper Limb
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Investigations - Other, Eosinophilia
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Behaviour Disturbance
5%
Scalp Pain
5%
Psychiatric Disorders - Other, Mood Swings
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Myalgia
5%
Tooth Infection
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
JOINT RANGE OF MOTION DECREASED
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
Peripheral Motor Neuropathy
5%
Scalp Lesion
5%
Sore Throat
5%
Tachycardia
5%
INSOMNIA
5%
URINARY URGENCY
5%
Allergic Rhinitis
5%
Peripheral Sensory Neuropathy
5%
HEMATURIA
5%
RASH
5%
Infections And Infestations - Other, Covid-19
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Investigations - Other, International Normalized Ration Increased
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Stomach Pain
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Neuropathy
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
TENDONITIS
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Muscle Weakness Lower Limb
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2360

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,716 Total Patients Enrolled
49 Trials studying Prostate Cancer
34,628 Patients Enrolled for Prostate Cancer
ExelixisIndustry Sponsor
121 Previous Clinical Trials
20,128 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
~9 spots leftby Jul 2026
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