A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-21

Study Completion Date

2017-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6. CDK4/6 is involved in the process that allows both normal and cancer cells to divide and multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may slow the growth of some cancers. LEE011 has shown anti-cancer activity in several different tumor models in animals.

Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease the ability of the bone marrow to make white blood cells, platelets, and red blood cells. Although these effects are expected to be reversible, they can increase the risk of infection, bleeding and fatigue.

The primary purpose of this study is to find the highest dose of LEE011 that can be safely given to adult patients with advanced solid tumors or lymphomas for which no further effective standard treatment is available. It will provide information about the side effects that may occur following treatment. The study will also possibly provide early evidence for LEE011's anti-tumor activity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

NCT02187783

Tumors With CDK4/6 Pathway Activation

COMPLETED PHASE2

A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors

NCT01106508

Advanced Solid Tumors Recurrent or Refractory Medulloblastoma Locally Advanced or Metastatic Basal Cell Carcinoma

COMPLETED PHASE1

Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors

NCT03237390

Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm

COMPLETED PHASE1

LY293111 in Treating Patients With Advanced Solid Tumors

NCT00006375

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Study of LM-061 in Subjects in Advanced Tumors

NCT04737122

Advanced Tumours

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumor Lymphomas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LEE011

Group Type EXPERIMENTAL

LEE011

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LEE011

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients aged ≥18 years with a histologically or cytologically confirmed diagnosis of a solid tumor or lymphoma for which no further effective standard treatment is available
2. Patients must have an ECOG performance status of 0 - 1
3. Patients enrolled in the dose expansion phase must have at least one measurable lesion as defined by RECIST criteria for solid tumors or Measurable nodal disease at baseline as defined by Cheson criteria for Lymphoma.
4. A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies and major surgery) and enrollment in this study, to allow the effects of prior therapy to have abated:

* Cytotoxic chemotherapy: ≥ the duration of the cycle of the most recent treatment regimen (a minimum of 2 weeks for all regimens, except 6 weeks for nitrosoureas and mitomycin-C).
* Biologic therapy (e.g., antibodies): ≥ 4 weeks.
5. Patients must have adequate organ function, as defined by the following parameters:

* Bone marrow: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 109/L
* Hepatic function: Serum total bilirubin ≤ 1.5 x ULN (upper limit of normal); AST (SGOT) and ALT (SGPT) ≤ 3 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN
* Renal function: Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 40 ml/min, Serum potassium, magnesium and calcium must be within normal limits

Exclusion Criteria

1. Patients with primary central nervous system tumors or brain metastases. However, if radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of 3 months demonstrates the disease to be stable and if the patient remains asymptomatic, then the patient may be enrolled. Such patients must have no need for treatment with steroids or anti-epileptic medications.
2. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of LEE011 such as patients with a history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, unresolved nausea, vomiting, or diarrhea of CTCAE grade \> 1
3. Prior hematopoietic stem cell or bone marrow transplantation
4. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:

* LVEF \<45% as determined by MUGA or echo
* Complete left bundle branch block
* Obligate use of a cardiac pacemaker or implantable cardioverter defibrillator
* Congenital long QT syndrome or family history of unexpected sudden cardiac death
* History or presence of ventricular tachyarrhythmia
* Presence of unstable atrial fibrillation (ventricular response \> 100 bpm
* Clinically significant resting bradycardia
* QTcF \>450 ms for males and \>470 ms for females on screening ECG
* Right bundle branch block and left anterior hemiblock (bifascicular block)
* Angina pectoris ≤ 3 months prior to dosing with study drug
* Acute MI ≤ 3 months prior to dosing with study drug
* Other clinically significant heart disease
5. Acute myocardial infarction or angina pectoris ≤ 3 months prior to starting study drug
6. Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g. uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection).

Known diagnosis of HIV or hepatitis C

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No