Status:
COMPLETED
A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumor
Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
- 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
Key Trial Info
Start Date :
December 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2017
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01237236
Start Date
December 21 2010
End Date
March 9 2017
Last Update
December 17 2020
Active Locations (7)
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1
Dana Farber Cancer Institute DFCI
Boston, Massachusetts, United States, 02215
2
University of Michigan Comprehensive Cancer Center SC
Ann Arbor, Michigan, United States, +1 48109 0944
3
Memorial Sloan Kettering MSKCC (2)
New York, New York, United States, 10017
4
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)
Nashville, Tennessee, United States, 37203