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Tyrosine Kinase Inhibitor
Cabozantinib for Thyroid Cancer
Phase 3
Waitlist Available
Research Sponsored by Exelixis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months after 100 subjects are randomized. time from randomization to best overall response of confirmed complete response (cr) or confirmed partial response (pr) per birc per recist 1.1.
Awards & highlights
Study Summary
This trial is testing whether a new drug called cabozantinib is better than placebo at treating patients with a certain type of thyroid cancer that has progressed after other treatments.
Who is the study for?
This trial is for adults with differentiated thyroid cancer that's gotten worse after treatment with specific drugs targeting blood vessel growth. They must have tried or be ineligible for Iodine-131 therapy, and can't have had more than two such prior treatments. Good physical health (ECOG 0 or 1) is required, and they shouldn't have received recent anticancer therapies or radiation, nor should they have certain brain metastases.Check my eligibility
What is being tested?
The study tests Cabozantinib against a placebo in patients whose thyroid cancer has not responded to previous treatments aimed at blocking blood vessel growth. It aims to see if Cabozantinib can slow the disease's progression and improve response rates compared to no active treatment.See study design
What are the potential side effects?
Cabozantinib may cause high blood pressure, diarrhea, weight loss, fatigue, nausea, mouth sores, hair color changes and hand-foot syndrome. Side effects vary by individual; some might experience few or none of these.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately twenty months after the first subject is randomized. time from randomization to the earlier of the following events: radiographic pd as determined by the blinded independent central review (birc) or death due to any cause.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately twenty months after the first subject is randomized. time from randomization to the earlier of the following events: radiographic pd as determined by the blinded independent central review (birc) or death due to any cause.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Progression Free Survival (PFS)
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%
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%
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%
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%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
RASH
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
SINUS BRADYCARDIA
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hoarseness
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Stomach Pain
5%
TENDONITIS
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CabozantinibExperimental Treatment1 Intervention
cabozantinib (60 mg) once daily orally (qd)
Group II: PlaceboPlacebo Group1 Intervention
placebo once daily orally (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?
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,041 Total Patients Enrolled
ExelixisLead Sponsor
117 Previous Clinical Trials
19,364 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received treatment with Iodine-131 for differentiated thyroid cancer (DTC) in the past, or you are not eligible for this treatment.You have already been treated with a specific type of medication for your thyroid cancer, and you may have been treated with up to two different medications of this type.You should be able to carry out all your normal activities without any restrictions or only have a little restriction in physically strenuous activity.You have had radiation treatment for cancer within the past few weeks.You have cancer that has spread to your brain, unless it has been treated well.You have been treated with certain specific medications, including cabozantinib, a BRAF kinase inhibitor, multiple VEGFR-targeting medications, more than one immune checkpoint inhibitor, or more than one chemotherapy regimen.You have taken any small molecule kinase inhibitor within 2 weeks or 5 half-lives of the drug before the study starts.You have a confirmed diagnosis of Differentiated Thyroid Cancer.You must have a measurable disease according to specific guidelines for evaluating tumors.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib
- Group 2: Placebo
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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are the common purposes of Cabozantinib?
"Cabozantinib has been approved for use in patients that have already received anti-VEGF agents. Additionally, this medication can be used to treat advanced renal cell carcinoma (ARCC), adrenal medulla tumors, and high risk patients."
Answered by AI
Is this a new or innovative clinical study?
"First developed and trialled in 2012 by Exelixis, cabozantinib has since been the subject of 116 clinical trials across 46 countries."
Answered by AI
Can you share any previous studies that have utilized Cabozantinib?
"There are 116 research studies involving Cabozantinib, with 13 of them being Phase 3 clinical trials. The vast majority of these trials take place in Cordoba and Calabria, but there are 7150 total locations running these studies."
Answered by AI
Are there any current vacancies for this research project?
"Presently, this study is not enrolling patients. Although, it's worth noting that the trial was originally posted on 10/5/2018 and was most recently edited on 7/13/2021. For individuals seeking other studies, there are presently 236 trials actively admitting participants with thyroid adenoma and 116 studies for Cabozantinib recruiting patients."
Answered by AI
How many people can join this clinical trial at the most?
"This particular study has completed recruitment and is no longer enrolling patients. The trial was initially posted on 10/5/2018, with the most recent update being 7/13/2021. However, there are presently 236 studies actively enrolling participants with thyroid adenoma and 116 studies for Cabozantinib actively enrolling participants."
Answered by AI
What are the potential dangers of taking Cabozantinib?
"There is a significant body of evidence attesting to cabozantinib's safety, as it has progressed to Phase 3 clinical trials."
Answered by AI
From how many places is this clinical trial being overseen?
"To make participation easier for patients, this trial is enrolling at 35 locations. The sites are situated in Ann Arbor, Columbia and Saint Louis as well as 32 other cities."
Answered by AI
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