Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Cabozantinib for Liver Cancer
Phase 1 & 2
Waitlist Available
Led By Vaibhav Sahai, MBBS, MS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a radiologically consistent (early enhancement and delayed enhancement washout) or pathologically confirmed diagnosis of hepatocellular carcinoma that is not eligible for curative resection, transplantation, or ablative therapies.
Must have an ECOG performance status of 0-1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new drug, cabozantinib, to see if it is safe and effective in treating people with liver cancer that has spread and who also have cirrhosis.
Who is the study for?
This trial is for adults with advanced liver cancer (hepatocellular carcinoma) who have cirrhosis classified as Child-Pugh class B and have already tried one systemic therapy. They should not be eligible for curative surgery or other local treatments, must have measurable disease, good performance status (able to carry out daily activities), and adequate organ function. Pregnant women, those with recent major surgeries or active secondary cancers, uncontrolled medical conditions, or certain heart issues are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a drug called Cabozantinib in patients with hepatocellular carcinoma that cannot be removed by surgery and has spread beyond the liver. The focus is on those who also suffer from moderate liver dysfunction (Child-Pugh class B cirrhosis) after first-line treatment.See study design
What are the potential side effects?
Cabozantinib may cause side effects such as diarrhea, high blood pressure, fatigue, loss of appetite, weight loss, nausea/vomiting; it can also affect how wounds heal and might lead to serious complications like bleeding or holes in the stomach/intestine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer can't be cured with surgery, transplant, or targeted therapies.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I can undergo CT or MRI scans with contrast without issues.
Select...
My cancer can be measured on scans and has grown after specific treatments.
Select...
My liver function score is either B7 or B8.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D)
Secondary outcome measures
Median time to progression (TTP)
Overall response rate (ORR) (partial response + complete response)
Overall survival (OS)
+2 moreSide 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%
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%
Hoarseness
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
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
1Treatment groups
Experimental Treatment
Group I: CabozantinibExperimental Treatment1 Intervention
Cabozantinib 20-60 mg by mouth once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,094 Total Patients Enrolled
4 Trials studying Liver Cancer
866 Patients Enrolled for Liver Cancer
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,548 Total Patients Enrolled
1 Trials studying Liver Cancer
Vaibhav Sahai, MBBS, MSPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
216 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't needed fluid removed from my abdomen or been hospitalized for liver-related brain issues recently.My condition worsened or I couldn't tolerate my first cancer treatment, and I haven't had cabozantinib.I can undergo CT or MRI scans with contrast without issues.I haven't had heart failure, uncontrolled high blood pressure, or a stroke in the last 6 months.My cancer is affecting major blood vessels, but not due to liver disease.I do not have any serious health issues that would make it unsafe for me to join the study.I have never had an organ transplant.My brain metastasis has been treated and stable for 4 weeks without steroids.My organs are working well, as tested within the last 2 weeks.My liver cancer can't be cured with surgery, transplant, or targeted therapies.I do not have any severe, uncontrolled illnesses.I haven't had major surgery in the last 8 weeks or minor surgery in the last 10 days.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use two forms of birth control or abstain from sex during and 4 months after the study.I have lung lesions or disease in my airways.I am not pregnant or breastfeeding.You are willing to provide a sample of tissue that was taken during a previous diagnostic biopsy, if you have one available.I have recovered from previous treatment side effects, or they are stable and not serious.I don't have another active cancer besides non-dangerous skin cancer or treated cervical cancer.I am not taking blood thinners like warfarin or clopidogrel.My heart's electrical activity is normal as per my recent ECG.I had liver treatment or surgery over 4 weeks ago, or other radiation over 2 weeks ago with minimal side effects.I have not had significant bleeding in the last 3 months.I don't have untreated bleeding varices or those at high risk of bleeding.I have a serious gut condition that could lead to holes or abnormal connections in my intestines.My cancer can be measured on scans and has grown after specific treatments.I am not taking strong CYP3A4 affecting drugs, or can stop them 14 days before the study starts.My liver function score is either B7 or B8.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib
Awards:
This trial has 1 awards, including:- 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 a similar investigation ever been conducted before?
"Presently, there are 109 ongoing clinical trials for Cabozantinib which span 45 nations and 1315 cities. The first of these studies was initiated in 2012 by Exelixis and ultimately attained its Phase 2 approval following the recruitment 86 patients. Since then, 55 additional investigations have been concluded."
Answered by AI
Has Cabozantinib been previously scrutinized in other scientific trials?
"At present, 109 trials are ongoing for Cabozantinib with 11 of these being at the Phase 3 stage. Despite most studies taking place in Cordoba and Calabria, this treatment is accessible to patients across 6848 various sites worldwide."
Answered by AI
What medical conditions has Cabozantinib been found to ameliorate?
"Cabozantinib offers a possible treatment for those who have endured anti-VEGF therapy and suffer from advanced renal cell carcinoma (ARCC) or adrenal medulla."
Answered by AI
How many participants is this research endeavor recruiting?
"In order to execute this trial, Exelixis needs 32 participants that meet the selection criteria. The study is situated in two distinct locations: University of Michigan Rogel Cancer Center in Ann Arbor, Michigan and University of Chicago in Dallas, Texas."
Answered by AI
Are there any openings remaining for this research study?
"Per the information on clinicaltrials.gov this medical trial is actively recruiting patients. The study was published on 6th August 2021, and underwent its last update on 15th August 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger