LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma

Stopped early · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

The purpose of this study is determine whether the combination therapy with LEE011 and chemoembolization in patients with locally advanced Hepatocellular Carcinoma not amenable to curative therapies will provide greater efficacy than chemoembolization alone with a tolerable safety profile.

Key facts

Study ID

NCT02524119

Run by

University of Texas Southwestern Medical Center

People needed

5

Starts

2016-04-01

Expected to finish

2020-09-01

Last updated by the study team

2021-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have a histologically confirmed diagnosis of RB positive hepatocellular carcinoma
• Patients must have HCC limited to the liver. There must be no clinical or radiographic evidence of extrahepatic HCC. Portal lymphadenopathy is permitted as lymphadenopathy is commonly associated with cirrhosis unrelated to malignancy;
• Absence of occlusive main portal vein thrombus, branch venous thrombus is allowed;
• Patients with locally advanced HCC not eligible for curative therapies;
• Age ≥ 18 years;
• Child-Pugh Score A or B7;
• ECOG (Eastern Cooperative Oncology Group) Performance score of 0-2;
• Life expectancy greater than 6 months;
• Following baseline laboratory values:
• Total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome;
• INR (international normalized ratio) ≤ 1.7;
• Hgb ≥ 9.0 g/dl;
• Alkaline Phosphatase, AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) <7 times ULN;
• Platelet count ≥ 75,000/mm3;
• Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min;
• Absolute neutrophil ≥ 1,500 cells/mm3;
• Potassium, total calcium (corrected for serum albumin), magnesium, and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
• Sodium >130 meq/L;
• Women of childbearing potential must have a negative pregnancy test;
• Prior therapy is allowed provided the following are met: at least 4 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation. Provided target lesion has increased in size by 25% or more or the target lesion was not treated with locoregional therapy;
• Must be able to swallow LEE011 capsules.

You may not qualify if…

• Patient who received any CDK4/6 inhibitor (cyclin-dependent kinase 4);
• Patient who has received previous systemic therapy;
• Patients with central nervous system (CNS) involvement, unless they meet ALL of the following criteria:
• At least 4 weeks from prior therapy completion (including ration and/or surgery) to starting the study treatment;
• Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases;
• Clinically significant, uncontrolled heart disease and/or recent events including any of the following:
• History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to screening;
• History of documented congestive heart failure (New York Heart Association functional classification III-IV);
• Documented cardiomyopathy;
• Patient has a left ventricular ejection fraction <50% as determined by MUGA (Multi Gated Acquisition scan) or ECHO at screening;
• History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrythmias, or conduction abnormality within 12 months of screening;
• Bradycardia (heart rate <50 at rest), by ECG or pulse, at screening;
• Congenital long QT syndrome or family history of long QT syndrome;
• Systolic Blood Pressure (SBP) >160 or <90 mm Hg;
• On screening inability to determine the QTcF (Fridericia Correction Formula) interval on the ECG (i.e.: Unreadable or Not Interpretable) or QTcF > 450 msec (using Fridericia's correction). All as determined by screening ECG (mean of triplicate ECGs);
• Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to treatment (see appendix 1 for details):
• Known strong inducers or inhibitors of CYP3A4/5 (a member of the cytochrome P450), including grapefruit, grapefruit hybrids, pomelo, star-fruit, and Seville oranges;
• That have a known risk to prolong the QT interval or induce Torsades de Pointes
• Herbal preparations/medications, dietary supplements;
• That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5;
• Tumor involvement > 50% of the liver;
• Patient has a known history of HIV infection (testing is not required);
• Patient has any other concurrent sever and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.);
• Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks to starting study drug, or who have not fully recovered from side effects of such treatment
• The following uses of corticosteroids are permitted: single doses, topical applications (e.g.: for rash), inhaled sprays (e.g.: for obstructive airways diseases), eye drops or local injections (e.g.: intra-articular);

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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