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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%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
HEADACHE
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
Upper Respiratory Infection
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Rash Acneiform
14%
Pruritis
14%
Rash Maculopapular
14%
HYPOGLYCEMIA
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Allergic Rhinitis
5%
Hypotension
5%
Muscle Weakness Lower Limb
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Behaviour Disturbance
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
HEMATURIA
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Scalp Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Neuropathy
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
JOINT RANGE OF MOTION DECREASED
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
INSOMNIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Investigations - Other, International Normalized Ration Increased
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Joint Range Of Motion Decreased
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
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
~1760

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,084 Previous Clinical Trials
1,138,869 Total Patients Enrolled
48 Trials studying Prostate Cancer
34,567 Patients Enrolled for Prostate Cancer
ExelixisIndustry Sponsor
120 Previous Clinical Trials
20,100 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

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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