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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumor, Lymphomas

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Trial Information

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


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

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

12 month

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLEE011X2101

NCT ID:

NCT01237236

Start Date:

December 2010

Completion Date:

May 2014

Related Keywords:

  • Advanced Solid Tumor
  • Lymphomas
  • Advanced solid tumor
  • lymphoma
  • Lymphoma
  • Neoplasms

Name

Location

Dana Farber Cancer Institute DFCIBoston, Massachusetts  02115
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)Nashville, Tennessee  37203
University of Michigan Comprehensive Cancer Center SCAnn Arbor, Michigan  48109-0944
Memorial Sloan Kettering Cancer Center MSKCC (2)New York, New York  10021