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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
Must not have
Concomitant anticoagulation with specific agents
Inability to swallow tablets
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking blood thinners.
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I cannot swallow pills.
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My brain metastases have been treated.
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My tumor is of a type that grows and spreads quickly.
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I have been treated with cabozantinib before.
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I do not have any other cancer that needs treatment right now.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Establish objective response rate as measured by RECIST 1.1

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

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
121 Previous Clinical Trials
823,641 Total Patients Enrolled
ExelixisIndustry Sponsor
119 Previous Clinical Trials
19,913 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
67 Patients Enrolled for Neuroendocrine Tumors
Advanced Accelerator Applications SAUNKNOWN

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05249114 — Phase 1
Neuroendocrine Tumors Research Study Groups: Cohort 5, Cohort 1, Cohort 2, Cohort 3, Cohort 4
Neuroendocrine Tumors Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT05249114 — Phase 1
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05249114 — Phase 1
~1 spots leftby Dec 2024
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