Cabozantinib for Liver Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Princess Margaret Cancer Centre, Toronto, CanadaLiver Cancer+2 MoreCabozantinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess the effectiveness of cabozantinib in patients with recurrent liver cancer who have previously received a liver transplant.

Eligible Conditions
  • Liver Cancer
  • Recurrent Cancer
  • Liver Transplant

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 3 years

3 years
Number of Side Effects Reported
Overall survival
Progression-free survival
4 months
Disease control rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Cohort 1 - Cabozantinib, Trastuzumab for HER2+
76%Fatigue
52%Aspartate aminotransferase increased
48%Constipation
38%Nausea
38%Diarrhea
38%Headache
33%Palmar-plantar erythrodysesthesia syndrome
33%Mucositis oral
33%Hypertension
29%Alanine aminotransferase increased
24%Musculoskeletal and connective tissue disorder - Other, specify
19%Vomiting
19%Anorexia
19%Pain in extremity
19%Ataxia
19%Dizziness
19%Cough
19%Skin and subcutaneous tissue disorders - Other, specify
19%Serum amylase increased
14%Rash maculo-papular
14%Flatulence
14%Eye disorders - Other, specify
14%Pain
14%Hyponatremia
14%Insomnia
14%Lipase increased
14%Blood and lymphatic system disorders - Other, specify
14%Dysarthria
14%Hypothyroidism
14%Blurred vision
14%Abdominal pain
14%Dysgeusia
10%Muscle weakness lower limb
10%Rash acneiform
10%Back pain
10%Generalized muscle weakness
10%Platelet count decreased
10%Gastrointestinal disorders - Other, specify
10%Gait disturbance
10%General disorders and administration site conditions - Other, specify
10%Weight loss
10%Investigations - Other, specify
10%Hyperglycemia
10%Peripheral sensory neuropathy
10%Tremor
10%Tracheal fistula
10%Voice alteration
10%Alopecia
10%Ejection fraction decreased
10%Pancreatitis
10%Gastroesophageal reflux disease
10%Stomach pain
5%Muscle weakness upper limb
5%Thromboembolic event
5%Productive cough
5%Dysmenorrhea
5%Anemia
5%Palpitations
5%Dry eye
5%Colitis
5%Duodenal hemorrhage
5%Eye infection
5%Skin infection
5%Vaginal infection
5%Bruising
5%Injury, poisoning and procedural complications - Other, specify
5%Dehydration
5%Blood bilirubin increased
5%Hypoglycemia
5%Hypomagnesemia
5%Arthralgia
5%Myalgia
5%Neck pain
5%Cognitive disturbance
5%Nervous system disorders - Other, specify
5%Confusion
5%Depression
5%Urinary incontinence
5%Dyspnea
5%Epistaxis
5%Dry skin
5%Hot flashes
5%Vascular disorders - Other, specify
5%Papulopustular rash
5%Upper respiratory infection
5%Hearing impaired
5%Vertigo
5%Ear pain
5%Bloating
5%Seizure
5%Urinary urgency
5%Toothache
5%Dry mouth
5%Edema trunk
5%Dysphagia
5%Activated partial thromboplastin time prolonged
5%Hemorrhoids
5%Urinary tract infection
5%Sinus pain
5%Facial nerve disorder
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02260531) in the Cohort 1 - Cabozantinib, Trastuzumab for HER2+ ARM group. Side effects include: Fatigue with 76%, Aspartate aminotransferase increased with 52%, Constipation with 48%, Nausea with 38%, Diarrhea with 38%.

Trial Design

1 Treatment Group

Cabozantinib
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Cabozantinib · No Placebo Group · Phase 2

Cabozantinib
Drug
Experimental Group · 1 Intervention: Cabozantinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,386 Previous Clinical Trials
471,949 Total Patients Enrolled
3 Trials studying Liver Cancer
51 Patients Enrolled for Liver Cancer
IpsenIndustry Sponsor
325 Previous Clinical Trials
69,300 Total Patients Enrolled
Jennifer Knox, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
57 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least three more months.
You had a liver transplant in the past to treat liver cancer.
Your disease cannot be treated with surgery or local therapies that can cure it.
You have previously experienced side effects from a treatment, but they have improved and are now mild or resolved completely.

Frequently Asked Questions

How many people total are participating in this experiment?

"Yes, this is an active trial that was posted on August 7th, 2020 and updated most recently on April 11th, 2021. They are looking for 20 individuals at a single site." - Anonymous Online Contributor

Unverified Answer

Are there any current openings for volunteers in this experiment?

"The clinical trial is currently looking for 20 more participants and is enrolling at 1 site. The information was found on clinicaltrials.gov, where the study was originally posted on 8/7/2020 and edited on 4/11/2021." - Anonymous Online Contributor

Unverified Answer

Are there other ongoing research projects that investigate Cabozantinib?

"At the moment, there are 116 ongoing studies looking into the effects of cabozantinib. Of these, 13 are in phase 3. Many of the trials for cabozantinib are taking place in Cordoba and Calabria, but there are 7151 clinical trial sites across the globe." - Anonymous Online Contributor

Unverified Answer

Is there a large margin of safety for Cabozantinib?

"There is some data supporting Cabozantinib's safety, but none showing that it is an effective treatment. It received a score of 2." - Anonymous Online Contributor

Unverified Answer

Does this research have any predecessors?

"First researched in 2012, Cabozantinib has had 86 patients in its initial study. After the first Phase 2 trial, it was approved for use and there are currently 116 live studies being conducted across 1375 cities and 46 countries." - Anonymous Online Contributor

Unverified Answer

What are the standard applications for Cabozantinib?

"Patients who have received anti-vegf treatment, those with advanced renal cell carcinoma (arcc), and patients with adrenal medulla can all be treated using Cabozantinib." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.