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Tyrosine Kinase Inhibitor
Cabozantinib + Lu-177 for Neuroendocrine Cancer
Phase 1
Waitlist Available
Led By Hagen Kennecke, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with unresectable, progressive, histologically well-differentiated neuroendocrine tumors of the fore-, mid-, or hindgut, including pancreas, or those with an unknown primary with target lesions overexpressing somatostatin receptors (Krenning 2, 3 or 4) on a SSTR PET
Minimum 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing different doses of a drug in combination with another drug to see what the maximum tolerated dose is.
Who is the study for?
Adults with well-differentiated neuroendocrine tumors who have had prior systemic therapy, including somatostatin analogue therapy. They should be in good physical condition (ECOG 0-2), have adequate organ and marrow function, and not be pregnant or breastfeeding. Participants must agree to use contraception during the study and for 4 months after.Check my eligibility
What is being tested?
The trial is testing different doses of Cabozantinib (20 mg, 40 mg, and 60 mg) combined with a standard dose of Lu-177 dotatate given in four cycles over eight weeks each. The goal is to find the highest dose that patients can tolerate without severe side effects.See study design
What are the potential side effects?
Potential side effects include high blood pressure, bleeding events such as coughing up blood or nosebleeds, gastrointestinal issues like bowel obstruction or abdominal abscesses within six months before treatment starts, significant heart arrhythmias or failure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is a type of neuroendocrine tumor that cannot be surgically removed and is growing.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of the day.
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My blood tests show my organs and bone marrow are working well.
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I am not pregnant.
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I have been treated with at least one type of systemic therapy, including a somatostatin analogue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish the maximal tolerated dose of cabozantinib in combination with Lu-177 dotatae at a standard dose of 7.4 GBg in four 8-week cycles followed by continuation of cabozantinib.
Secondary outcome measures
Establish objective response rate as measured by RECIST 1.1
Side 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%
PAIN IN EXTREMITY
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
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%
ALKALINE PHOSPHATASE INCREASED
9%
ORAL PAIN
9%
TUMOR PAIN
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%
RASH
5%
Peripheral Sensory Neuropathy
5%
SINUS BRADYCARDIA
5%
HEMATURIA
5%
HYPERTHYROIDISM
5%
Sore Throat
5%
Hypertension
5%
ANXIETY
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Hoarseness
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Stomach Pain
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
TENDONITIS
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
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment2 Interventions
Cabozantinib 60 mg qd with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 60 mg qd until disease progression.
Group II: Cohort 4Experimental Treatment2 Interventions
Cabozantinib 60 mg qod alternating with 40 mg qod with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 60 mg qd.
Group III: Cohort 3Experimental Treatment2 Interventions
Cabozantinib 40 mg qd with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 40 mg qd.
Group IV: Cohort 2Experimental Treatment2 Interventions
Cabozantinib 40 mg qod alternating with 20 mg qod with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 40 mg qd.
Group V: Cohort 1Experimental Treatment2 Interventions
Cabozantinib 20 mg daily with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 20 mg qd.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
115 Previous Clinical Trials
122,517 Total Patients Enrolled
ExelixisIndustry Sponsor
116 Previous Clinical Trials
18,080 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
67 Patients Enrolled for Neuroendocrine Tumors
Advanced Accelerator Applications SAUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I previously had PRRT and it worked for at least 18 months before my condition worsened.My tumor is a type of neuroendocrine tumor that cannot be surgically removed and is growing.I do not have any major health issues like heart problems, serious wounds, or severe liver issues.I am 18 years old or older.I haven't taken any kinase inhibitor medication in the last 2 weeks.I have recovered from previous cancer treatment side effects, or they are minor and stable.I am currently taking blood thinners.I can take care of myself and am up and about more than half of the day.I cannot swallow pills.I have had up to 4 doses of PRRT therapy.My brain metastases have been treated.My tumor is of a type that grows and spreads quickly.My blood tests show my organs and bone marrow are working well.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I am not pregnant.I have been treated with cabozantinib before.I have been treated with at least one type of systemic therapy, including a somatostatin analogue.I haven't had cancer treatment in the last 4 weeks.I do not have any other cancer that needs treatment right now.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 5
- Group 2: Cohort 1
- Group 3: Cohort 2
- Group 4: Cohort 3
- Group 5: Cohort 4
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Has Cabozantinib obtained regulatory approval from the U.S. Food and Drug Administration?
"Cabozantinib's safety rating is only 1, given the limited data demonstrating its efficacy during Phase 1 trials."
Answered by AI
Does this experiment have any open slots for participants?
"Clinicaltrials.gov attests that this research project, established December 1st 2022 and last updated February 10th 2022, is not presently seeking participants. Despite the inactivity of this trial, it should be noted that there are still 165 other medical studies actively recruiting candidates at present time."
Answered by AI
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