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Tyrosine Kinase Inhibitor
Cabozantinib + 177Lu-PSMA-617 for Prostate Cancer (CaboLu Trial)
Phase 1
Recruiting
Led By Umang Swami, MD
Research Sponsored by University of Utah
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 3 years
Awards & highlights
CaboLu Trial Summary
This trial tests the safety & effectiveness of a drug combo for advanced prostate cancer. It'll assess how well the combo works & identify the best dosage.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread. They must have had specific prior treatments, including hormone therapies and chemotherapy, show PSMA-positive lesions, be in good physical condition (ECOG ≤1), have proper organ function, and agree to use contraception. Excluded are those with certain severe illnesses or recent surgeries, uncontrolled hypertension, brain metastases not stable for 4 weeks, active infections like HIV or hepatitis B/C.Check my eligibility
What is being tested?
The study is testing different doses of Cabozantinib combined with a radioactive drug called Lutetium-177 PSMA-617 on men with metastatic castration-resistant prostate cancer (mCRPC). It aims to find the highest dose patients can take without serious side effects (MTD) before expanding the trial.See study design
What are the potential side effects?
Possible side effects include high blood pressure; hand-foot skin reactions; fatigue; weight loss; changes in taste sensation; gastrointestinal symptoms like nausea and diarrhea; risk of bleeding or holes in stomach/intestine wall.
CaboLu Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of patients without progression as defined by PCWG3-modified RECIST 1.1 at 24 weeks.
The rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
Secondary outcome measures
Therapeutic procedure
Disease
OS as defined as the time from registration until death from any cause.
+5 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%
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%
RASH
5%
Hoarseness
5%
INSOMNIA
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Peripheral Sensory Neuropathy
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%
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, Dental Pain
5%
TENDONITIS
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
CaboLu Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion Cohort (Part 2)Experimental Treatment1 Intervention
Expansion Phase to assess identified MTD and schedule from Part 1.
Group II: Dose Escalation (Part 1)Experimental Treatment1 Intervention
Part 1 will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the MTD and/or recommended dose and schedule
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?
University of UtahLead Sponsor
1,100 Previous Clinical Trials
1,778,868 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,518 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,296 Patients Enrolled for Prostate Cancer
Umang Swami, MDPrincipal InvestigatorHuntsman Cancer Institute
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 18 or older.I have been treated with cabozantinib before.I have had surgery recently.I am experiencing symptoms related to spinal cord pressure.I do not have an active infection like TB, hepatitis B, or C.I have recently undergone radiation therapy or treatment with radioactive substances.I have completed at least 2 cycles of chemotherapy that included a drug like docetaxel.I haven't had certain cancer treatments recently.I don't have serious wounds, thyroid issues, severe liver problems, or recent COVID-19.My brain metastases are treated and stable.I have been treated with a newer hormone therapy for my cancer.I have HIV with a detectable viral load.I have recovered from side effects of previous treatments, with mild or no current side effects.I do not have any uncontrolled serious illnesses like heart or stomach problems.I cannot swallow pills.My prostate cancer is confirmed and not of the small cell type.I have undergone orchiectomy or am on hormone therapy with low testosterone levels.I am fully active or can carry out light work.I am currently taking certain blood thinners.My prostate cancer is worsening despite treatment.I have a history of significant bleeding or lung cavities.My blood, liver, and kidney functions are all within normal ranges.My surgical wounds have not fully healed.My cancer has spread, and tests show it's mostly PSMA-positive.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation (Part 1)
- Group 2: Dose Expansion Cohort (Part 2)
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.
How hazardous is the Dose Expansion Cohort (Part 2) for those who partake?
"The safety of Dose Expansion Cohort (Part 2) was given a rating of 1 on the Power team's scale, due to limited data available for evaluating its efficacy and security."
Answered by AI
To what end are the results of this research endeavor being pursued?
"This 24-week trial aims to measure the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period, as well as overall survival from registration to death from any cause. Additionally, Prostate Specific Antigen (PSA) levels will be monitored and compared against baseline levels until PSA progression is observed according to PCWG3 criteria. Finally, this study will also gauge Progression Free Survival at 38 weeks and evaluate patients without progress based on PCWG3 modified RECIST 1.1 standards"
Answered by AI
Are there any openings for new participants in this research endeavor?
"According to the clinicaltrials.gov website, this research is no longer accepting volunteers. The study was originally posted on May 1st 2023 and last modified 11th October 2022; consequently, it is not taking in any more candidates at present. Nevertheless, there are 1258 other trials currently open for registration."
Answered by AI
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