Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy
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|ClinicalTrials.gov Identifier: NCT04497038|
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : February 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Adult Hepatocellular Carcinoma||Drug: Cabozantinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Trial to Evaluate Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy|
|Estimated Study Start Date :||April 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||April 2026|
Cabozantinib 20-60 mg by mouth once daily.
Patients will receive therapy with cabozantinib. Dosage in the trial will start at 40 mg PO daily. Each patient will be assessed for the development of toxicity according to the NCI Common Terminology Criteria for Adverse Events, version 5.0. Dose adjustments may be made per the Time-To-Event modification of the Continual Reassessment Method (TITE-CRM). The maximum dosage will be 60 mg PO daily and the minimum will be 20 mg PO daily.
- Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) [ Time Frame: Up to 29 days after initiating treatment ]MTD/RP2D determined by dose limiting toxicities (DLT) during the first 29 days of therapy. DLTs are outlined in the protocol and assessed per the NCI CTCAE v5.0. The MTD/RP2D will be determined as the dose level with the highest probability of DLT not exceeding 35%.
- Progression-free survival (PFS) [ Time Frame: Up to 3 years ]PFS defined as time from date of treatment to date of radiological or clinical progressing (leading to withdrawal from the study), or death from any cause, whichever comes first. PFS will be estimated using the product-limit method of Kaplan and Meier.
- Median time to progression (TTP) [ Time Frame: Until date of last disease evaluation (up to 2 years) ]TTP defined as time from date of treatment to date of radiological or clinical progression (leading to withdrawal from the study).
- Overall survival (OS) [ Time Frame: Up to 3 years ]Patients will be followed for up to 2 years from treatment discontinuation or until death, whichever comes first, or 3 years after first date of treatment initiation for those that remain on treatment. OS will be estimated using the product-limit method of Kaplan and Meier.
- Overall response rate (ORR) (partial response + complete response) [ Time Frame: Up to 2 years ]ORR (PR + CR) per RECIST v1.1 criteria during active study treatment.
- Pharmacokinetic (PK) profile: Elimination clearance (L/hr) [ Time Frame: Up to 2 months ]Blood draws pre-dose, every 2 weeks until the start of cycle 3
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): NCT04497038
|Contact: Cancer Answer Line||800-865-1125||CancerAnswerLine@med.umich.edu|
|United States, Michigan|
|University of Michigan Rogel Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Thomas Enzler, MD 800-865-1125 CancerAnswerLine@med.umich.edu|
|Principal Investigator: Thomas Enzler, MD|
|Principal Investigator:||Vaibhav Sahai, MBBS, MS||University of Michigan|