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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR ABEMACICLIB

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Clinical Trials for Abemaciclib

Trial ID Title Status Sponsor Phase Summary
NCT01394016 A Phase 1 Study of LY2835219 In Participants With Advanced Cancer Active, not recruiting Eli Lilly and Company Phase 1 The purpose of this study is to determine a safe dose of LY2835219 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2835219 in this population. Efficacy measures will be used to assess the activity of LY2835219 in this population.
NCT01739309 Study of LY2835219 for Mantle Cell Lymphoma Active, not recruiting Eli Lilly and Company Phase 2 The purpose of this study is to estimate the disease control rate with LY2835219 for relapsed or refractory mantle cell lymphoma.
NCT01913314 A Study of ^14C-LY2835219 in Healthy Participants Completed Eli Lilly and Company Phase 1 This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. This study will help understand how the drug appears in the blood, urine, and stool after it is administered. In addition, this study will also evaluate the safety and tolerability of a single dose of LY2835219 when given to healthy participants. Information about any side effects that may occur will also be collected. This study will last about 3 weeks for each participant, not including screening.
NCT02014129 A Study of LY2835219 in Japanese Participants With Advanced Cancer Active, not recruiting Eli Lilly and Company Phase 1 The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.
NCT02057133 A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread Recruiting Eli Lilly and Company Phase 1 The main purpose of this study is to evaluate the safety of a study drug known as LY2835219 in combination with different therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, or LY3023414 plus fulvestrant) for breast cancer that has spread to other parts of the body.
NCT02059148 A Study of LY2835219 in Healthy Participants Completed Eli Lilly and Company Phase 1 Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.
NCT02079636 A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC) Recruiting Merck Sharp & Dohme Corp. Phase 1 The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage IV). The study will also investigate how the body processes the combination treatment and how the study drug affects the body. The study will also collect disease-related symptoms and participant-reported pain related to NSCLC.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Abemaciclib

Condition Name

Condition Name for Abemaciclib
Intervention Trials
Breast Cancer 9
Advanced Cancer 5
Healthy 5
Metastatic Breast Cancer 4
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Condition MeSH

Condition MeSH for Abemaciclib
Intervention Trials
Breast Neoplasms 17
Neoplasm Metastasis 7
Neoplasms 7
Carcinoma, Non-Small-Cell Lung 7
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Clinical Trial Locations for Abemaciclib

Trials by Country

Trials by Country for Abemaciclib
Location Trials
United States 254
Spain 20
France 17
Belgium 11
Korea, Republic of 11
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Trials by US State

Trials by US State for Abemaciclib
Location Trials
Texas 20
Massachusetts 16
Tennessee 15
New York 15
California 15
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Clinical Trial Progress for Abemaciclib

Clinical Trial Phase

Clinical Trial Phase for Abemaciclib
Clinical Trial Phase Trials
Phase 3 5
Phase 2 22
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Abemaciclib
Clinical Trial Phase Trials
Recruiting 22
Not yet recruiting 14
Completed 8
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Clinical Trial Sponsors for Abemaciclib

Sponsor Name

Sponsor Name for Abemaciclib
Sponsor Trials
Eli Lilly and Company 45
Dana-Farber Cancer Institute 4
Merck Sharp & Dohme Corp. 2
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Sponsor Type

Sponsor Type for Abemaciclib
Sponsor Trials
Industry 51
Other 16
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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Daiichi Sankyo
Cantor Fitzgerald
Chubb
Teva
Medtronic
US Army
Covington
UBS

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