Cabozantinib for Thyroid Adenoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Thyroid Adenoma+9 More
Cabozantinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether cabozantinib or lenvatinib can help patients lose weight, muscle, or fat.

Eligible Conditions
  • Thyroid Adenoma
  • Thyroid Gland Medullary Carcinoma
  • Pheochromocytoma
  • Carcinoma
  • Paraganglioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Thyroid Adenoma

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 12 months

Month 12
Change in adipose tissue in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia
Anorexia
Anorexia
Quality of life change
Month 6
Change in weight among patients who have no gastrointestinal (GI) adverse events (AEs) or have =< grade 1 symptoms and those with grade 2 or above AEs, according to the National Cancer Institute Common Toxicity Criteria version 4.0
Up to 12 months
Tumor response

Trial Safety

Safety Progress

1 of 3

Other trials for Thyroid Adenoma

Side Effects for

Cohort 3 - Cabozantinib for ER-, PR-, HER2-
88%Fatigue
63%Vomiting
50%Pain
38%Musculoskeletal and connective tissue disorder - Other, specify
38%Aspartate aminotransferase increased
38%Diarrhea
38%Alanine aminotransferase increased
25%Pain in extremity
25%Skin and subcutaneous tissue disorders - Other, specify
25%Dehydration
25%Nausea
25%Gastrointestinal disorders - Other, specify
25%Anorexia
25%Dysgeusia
25%Back pain
25%Cough
25%Anxiety
25%Insomnia
25%Dry skin
25%Constipation
25%Mucositis oral
13%Hypertension
13%Lipase increased
13%Hypomagnesemia
13%Rash maculo-papular
13%Ataxia
13%Neck pain
13%Platelet count decreased
13%Palmar-plantar erythrodysesthesia syndrome
13%Alkaline phosphatase increased
13%Dry mouth
13%General disorders and administration site conditions - Other, specify
13%Bruising
13%Blood bilirubin increased
13%Epistaxis
13%Headache
13%Tracheal fistula
13%Depression
13%Irregular menstruation
13%Personality change
13%Nail discoloration
13%Upper respiratory infection
13%Seizure
13%Thromboembolic event
13%Hyponatremia
13%Bloating
13%Blood and lymphatic system disorders - Other, specify
13%Gastroesophageal reflux disease
13%Endocrine disorders - Other, specify
13%Dysphasia
13%Hypothyroidism
13%Dyspepsia
13%Abdominal pain
13%Peripheral sensory neuropathy
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02260531) in the Cohort 3 - Cabozantinib for ER-, PR-, HER2- ARM group. Side effects include: Fatigue with 88%, Vomiting with 63%, Pain with 50%, Musculoskeletal and connective tissue disorder - Other, specify with 38%, Aspartate aminotransferase increased with 38%.

Trial Design

1 Treatment Group

Cabozantinib or Lenvatinib
1 of 1
Experimental Treatment

23 Total Participants · 1 Treatment Group

Primary Treatment: Cabozantinib · No Placebo Group · N/A

Cabozantinib or LenvatinibExperimental Group · 7 Interventions: Quality-of-Life Assessment, Questionnaire Administration, Computed Tomography, Cabozantinib, Lenvatinib, Dual X-ray Absorptiometry, Physical Examination · Intervention Types: Other, Other, Procedure, Drug, Drug, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Cabozantinib
FDA approved
Lenvatinib
FDA approved
Dual X-ray Absorptiometry
2019
N/A
~30
Physical Examination
2019
N/A
~1040

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,865 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,740 Total Patients Enrolled
Naifa L BusaidyPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.