LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001)
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|ClinicalTrials.gov Identifier: NCT02524119|
Recruitment Status : Terminated (This study was terminated after the sponsor withdrew our support)
First Posted : August 14, 2015
Results First Posted : February 1, 2021
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: LEE011 Procedure: Chemoembolization||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of LEE011 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||September 2020|
|Actual Study Completion Date :||September 2020|
Experimental: LEE001 with Chemoembolization
A total of 40 patients will be enrolled and undergo chemoembolization. Patients will receive LEE011 (600 mg PO once daily, 3 weeks on/1 week off) on Day 1 with chemoembolization. Patients can receive a total of 4 chemoembolization treatments within 6 month following first treatment as needed to treat initial HCC lesion.
600 mg PO once daily will be given orally on days 1-21 of a 28 day cycle (3 weeks on / 1 week off) :until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason
Patients will be treated with chemoembolization once every 4 weeks with up to 4 total chemoembolizations within the first 6 months from the initial chemoembolization.
- Progression Free Survival [ Time Frame: Every 8 weeks for up to 3 years. ]CT Chest scans must be performed at baseline. CT-Chest/abdomen/pelvis must be performed every 8 weeks during the treatment phase (12 months). Once the patient has been discontinued from the study and enters the efficacy phase, radiological assessment (CT or MRI) will continue every 8 weeks until progression or for the first 12 months, whichever comes first. After a year, radiological (CT or MRI) assessments will be performed every 12 weeks for up to 1 year.
- Overall Survival [ Time Frame: Every 12 weeks for up to 3 years. ]CT Chest scans must be performed at baseline. CT-Chest/abdomen/pelvis must be performed every 8 weeks during the treatment phase (12 months). Once the patient has been discontinued from the study and enters the efficacy phase, radiological assessment (CT or MRI) will continue every 8 weeks until progression or for 3 years, whichever comes first. After a year, radiological (CT or MRI) assessments will be performed every 12 weeks for up to 3year.
- Number of Participants With Adverse Events [ Time Frame: Each visit for up to 3 years ]Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
- Tolerability, as Measured by Number of Adverse Events [ Time Frame: At each patient visit while on LEE001 for up to 3 years ]The tolerability of LEE in combination with chemoembolization will be measured by number of adverse events.
- Objective Response Rate (ORR) Based on mRECIST and RECIST 1.1 [ Time Frame: Every 8 weeks for 3 years ]ORR was defined as number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the RECIST 1.1.
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): NCT02524119
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Muhammad Beg, MD||University of Texas Southwestern Medical Center|