The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.
Official Title: A phase1 Multi-center, Open Label, Dose-escalation Study of Oral LEE011 in Patients With Advanced Solid Tumors or Lymphoma
Study ID: NCT01237236
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 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dana Farber Cancer Institute DFCI, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center SC, Ann Arbor, Michigan, United States
Memorial Sloan Kettering MSKCC (2), New York, New York, United States
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2), Nashville, Tennessee, United States
Novartis Investigative Site, Lyon Cedex, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Utrecht, , Netherlands
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR