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Advanced Solid TumorPhase 1NCT01237236

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

A Phase 1 study testing LEE011 in people with Advanced Solid Tumor and Lymphomas, run by Novartis Pharmaceuticals at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Lymphomas
What is being tested?
LEE011
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
7 sitesin 3 countries
Study dates
21 Dec 2010to 9 Mar 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Patients must have an ECOG performance status of 0 - 1
  • 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.
  • 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.
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  • 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

Who cannot join

  • 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.
  • 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
  • Prior hematopoietic stem cell or bone marrow transplantation
  • 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
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  • 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
  • Acute myocardial infarction or angina pectoris ≤ 3 months prior to starting study drug
  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

United States4 sites

  • University of Michigan Comprehensive Cancer Center SC

    Ann Arbor, Michigan, +1 48109 0944

  • Dana Farber Cancer Institute DFCI

    Boston, Massachusetts, 02215

  • Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering MSKCC (2)

    New York, New York, 10017

Other trials in United States

France2 sites

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Netherlands1 site

  • Novartis Investigative Site

    Utrecht, 3584CX

Other trials in Netherlands

About this study

Official title: A phase1 Multi-center, Open Label, Dose-escalation Study of Oral LEE011 in Patients With Advanced Solid Tumors or Lymphoma

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.

Being tested
LEE011
Keywords
Advanced solid tumor, lymphoma
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEE011Drug

Study groups in NCT01237236
Study groupRoleWhat they receive
LEE011ExperimentalNot described
Receives: Drug: LEE011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Measures: Maximum tolerated dose of LEE011 when administered orally once daily, as assessed by Frequency of DLTs as a function of LEE011 dose

    Measured: 12 month

Secondary outcomes (5)

  1. Safety and tolerability of LEE011, as assessed by grade and frequency of Adverse events, serious adverse events, and changes in lab values, vital signs and ECGs.

    Measured: 18 months

  2. The pharmacokinetics (PK) of LEE011 (AUC inf, Cmax, Tmax, T1/2)

    Measured: 18 months

  3. Any pharmacodynamic activity of LEE011 treatment, as assessed by changes from baseline in biomarkers associated with the pharmacologic activity of LEE011

    Measured: 18 months

  4. Antitumor activity that may be associated with LEE011 treatment, as assessed by CT/MRI Response Evaluation Criteria for Solid Tumors (RECIST) Criteria v1.0 or Cheson Criteria 2007 for lymphomas.

    Measured: 18 months

  5. Relationship between QTc prolongation and exposure to LEE011 and/or any of its relevant metabolites.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2010 (estimated)
  2. Study start21 Dec 2010
  3. Primary completion9 Mar 2017
  4. Study completion9 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01237236
Sponsor's protocol ID
CLEE011X2101
Other IDs
2009-017017-30, 2009
Status last verified
Aug 2018
First submitted
5 Nov 2010
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
No

Publications

  • Ji Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Aug;65(8):1217-1228. doi: 10.1007/s40262-026-01643-3. Epub 2026 Jun 23.

    PubMed 42334791

  • Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.

    PubMed 36800111

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LEE011 in people with Advanced Solid Tumor and Lymphomas, run by Novartis Pharmaceuticals at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measures: Maximum tolerated dose of LEE011 when administered orally once daily, as assessed by Frequency of DLTs as a function of LEE011 dose (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01237236, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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