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Tyrosine Kinase Inhibitor

A Phase II Trial of Cabozantinib for the Treatment of Radioiodine (RAI)-Refractory Differentiated Thyroid Carcinoma (DTC) in the First-line Setting

Phase 2
Waitlist Available
Led By Marcia Brose, MD, PhD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing whether a drug called cabozantinib is effective at treating patients with a type of thyroid cancer called differentiated thyroid cancer. The trial is open-label, which means that both the patients and doctors will know which patients are taking the drug. The trial is not randomized, which means that the patients will not be assigned to either a treatment group or a control group by chance. The starting dose of cabozantinib is 60mg taken orally once a day. The patients will be able to continue taking the drug as long as it is effective or until they experience side effects that are not tolerable.

Eligible Conditions
  • Thyroid Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ALANINE AMINOTRANSFERASE INCREASED
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%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Platelet Count Decreased
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Skin Hypopigmentation
23%
Decreased Platelet Count
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%
HYPOGLYCEMIA
14%
Pruritis
14%
Rash Maculopapular
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
CONSTIPATION
14%
Rash Acneiform
14%
Fever
9%
TUMOR PAIN
9%
NASAL CONGESTION
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%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Periodontal Disease
5%
Hypotension
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Joint Range Of Motion Decreased
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Investigations - Other, Eosinophilia
5%
ANXIETY
5%
Behaviour Disturbance
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Muscle Weakness Lower Limb
5%
Scalp Pain
5%
Psychiatric Disorders - Other, Mood Swings
5%
Sinus Tachycardia
5%
Myalgia
5%
Tooth Infection
5%
JOINT RANGE OF MOTION DECREASED
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
Muscle Weakness Upper Limb
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%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Stomach Pain
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Neuropathy
5%
TENDONITIS
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
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%
Urine Discoloration
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
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

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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open Label CabozantimibExperimental Treatment1 Intervention
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?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,312 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
465 Previous Clinical Trials
176,810 Total Patients Enrolled
Marcia Brose, MD, PhDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
3 Previous Clinical Trials
40 Total Patients Enrolled
~4 spots leftby Jan 2026