Cabozantinib to Treat Recurrent Liver Cancer Post Transplant
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|ClinicalTrials.gov Identifier: NCT04204850|
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : August 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Recurrent Cancer Liver Transplant||Drug: Cabozantinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Cabozantinib in the Treatment of Recurrent Hepatocellular Carcinoma Post Liver Transplant|
|Actual Study Start Date :||August 7, 2020|
|Estimated Primary Completion Date :||August 7, 2023|
|Estimated Study Completion Date :||February 7, 2024|
Cabozantinib, at a dose of 60 mg orally (by mouth), once a day (at bedtime), continuously.
Cabozantinib is a multi-tyrosine kinase inhibitor with activity against VEGFR 1,2,3, MET and AXL, as well as RET, KIT, ant FLT-3.
Other Name: CABOMETYX
- Disease control rate [ Time Frame: 4 months ]Proportion of patients with complete response + partial response + stable disease.
- Progression-free survival [ Time Frame: 3 years ]Duration of time from start of treatment to time of progression.
- Overall survival [ Time Frame: 3 years ]Duration of time from start of treatment to time of death.
- Number of Side Effects Reported [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204850
|Contact: Jennifer Knox, M.D.||email@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Jennifer Knox, M.D. 416-946-2399|
|Principal Investigator: Jennifer Knox, M.D.|
|Principal Investigator:||Jennifer Knox, M.D.||Princess Margaret Cancer Centre|