Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

  • STATUS
    Recruiting
  • End date
    Feb 7, 2024
  • participants needed
    20
  • sponsor
    University Health Network, Toronto
Updated on 18 April 2021
liver cancer
cancer
tyrosine
systemic therapy
serum pregnancy test
measurable disease
liver transplant
cabozantinib
RET
sorafenib
hepatocellular carcinoma
lenvatinib

Summary

This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients.

Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors.

All participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.

Description

The study has three main parts:

Screening: Participants will have test, procedures, and assessments done for safety and eligibility. Some may be done for research purposes only. Several visits may be needed to complete the screening part of the study.

Study Drug Period: During this part, participants will take the study drug as prescribed by the study doctor. While on the study drug, participants will visit the clinic about once a week for tests, procedures, and assessments for safety, eligibility, and research only purposes.

End of Study Drug Visit and Follow-up: Participants will be asked to make an End of Study Drug visit about 30 days after the last dose of study drugs for safety, eligibility, and research only purposes. After this visit, participants will continue to have follow-up visits about every 8 weeks. If participants are experiencing side effects, they will be followed weekly for about 4 weeks, then monthly until resolution or stabilization.

Details
Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, Liver transplant, Liver Transplantation, HEPATIC NEOPLASM, Liver Cancer, HEPATOCELLULAR CARCINOMA, Recurrent Carcinoma, Recurrent Cancer, Liver Cancer, Malignant Adenoma, Liver Transplantation, liver cell carcinoma
Treatment Cabozantinib
Clinical Study IdentifierNCT04204850
SponsorUniversity Health Network, Toronto
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have histologically or cytologically confirmed hepatocellular carcinoma that has recurred
Previously underwent a liver transplant as a curative treatment for hepatocellular carcinoma (HCC)
Not amenable to curative surgery or local treatment for recurrent disease
Must have measurable disease
No prior treatment with cabozantinib. May be systemic therapy nave or have received up to 1 line of prior therapy for advanced HCC with sorafenib or lenvatinib
Age 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 01
Life expectancy of >3 months
Normal organ and marrow function
Adequate cardiac function
No evidence of active uncontrolled infection
Understand and willing to sign written informed consent document
Recovered from prior toxicities to < grade 1
Able to take oral medications
Agree to use effective contraceptive methods until at least 30 days (for women) and 3 months (for men) after the last administration of study medication. Serum pregnancy test should be negative

Exclusion Criteria

Had systemic therapy or radiotherapy <3 weeks
Receiving any other investigational agents
With known brain metastases unless stable for >3 months
History of allergic reactions attributed to cabozantinib
Has uncontrolled, significant intercurrent or recent illness
Cardiovascular disorders
Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation
Major surgery within 2 months before randomization
Cavitating pulmonary lesion(s) or endobronchial disease (untreated)
Lesion invading a major blood vessel
Clinically significant bleeding risk <3 months
Other clinically significant disorders
Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)-related illness
Serious non-healing wound/ulcer/bone fracture
Malabsorption syndrome
Uncompensated/symptomatic hypothyroidism
Requirement for hemodialysis or peritoneal dialysis
Pregnant women
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
Active hepatitis B or C in liver graft
Patients with a grade >= 2 elevated liver enzymes who are suspected of cellular rejection will undergo biopsy. Patients diagnosed with cellular rejection in the biopsy sample using the Banff schema are ineligible
Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
Moderate or severe ascites
Concomitant use of anticoagulants at therapeutic doses
Has a known history of prior invasive malignancy except if patient has undergone curative-intent therapy with no evidence of disease recurrence for 2 years prior to study entry
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note