Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Gastrointestinal Agents

Anti-Infective Agents

Trastuzumab

Pertuzumab

Tamoxifen

Hormones

Everolimus

Fulvestrant

Exemestane

Letrozole

Loperamide

Anastrozole

Antineoplastic Agents, Immunological

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Antidiarrheals

LY2835219 administered orally. Letrozole administered orally. This arm is closed to enrollment.

LY2835219 administered orally. Anastrozole administered orally. This arm is closed to enrollment.

LY2835219 administered orally. Tamoxifen administered orally. This arm is closed to enrollment.

LY2835219 administered orally. Exemestane administered orally. This arm is closed to enrollment.

LY2835219 administered orally. Exemestane administered orally. Everolimus administered orally. This arm is closed to enrollment.

LY2835219 administered orally. Trastuzumab administered intravenously (IV) infusion. This arm is closed to enrollment.

LY2835219 administered orally. Trastuzumab administered IV infusion. This arm is closed to enrollment.

LY3023414 administered orally. LY2835219 administered orally. Fulvestrant administered intramuscularly (IM).

LY3023414 administered orally. LY2835219 administered orally. Fulvestrant administered IM.

LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion.

Hormone Receptor Negative (HR-): LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion.

Hormone Receptor Positive (HR+): LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion. Endocrine therapy administered orally.

LY2835219 administered orally. Ongoing endocrine therapy administered orally.

LY2835219

LY3023414

Endocrine therapy

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide, or ongoing endocrine therapy) for breast cancer that has spread to other parts of the body.

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

A Phase 1b Study of Abemaciclib in Combination With Therapies for Patients With Metastatic Breast Cancer

Number of participants with one or more drug-related adverse events

Cmax of LY2835219, letrozole, anastrozole, tamoxifen, exemestane, everolimus, trastuzumab, LY3023414, fulvestrant, and pertuzumab.

Number of participants with a complete or partial tumor response (overall response rate).

Change in MD Anderson (MDASI) score from baseline.

Pharmacokinetics: AUC of LY2835219, letrozole, anastrozole, tamoxifen, exemestane, everolimus, trastuzumab, LY3023414, fulvestrant, and pertuzumab.

Eli Lilly and Company

Rare Diseases

Sarcoma

Liposarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Adipose Tissue

Soft Tissue Sarcoma

Patients will be treated with abemaciclib 200 mg bid.

Abemaciclib

Mark Dickson, MD

The purpose of this study is to test any good and bad effects of the study drug called Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast cancer, lymphoma, and lung cancer.

Study of Abemaciclib in Dedifferentiated Liposarcoma

Phase 2 Study of Abemaciclib (LY2835219) in Dedifferentiated Liposarcoma

Progression includes both disease progression (as defined by RECIST 1.1) and death from any cause.

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Neoplasm Metastasis

Lymphoma

Neoplastic Processes

Lymphosarcoma

100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.

150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.

200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST)

The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.

A Study of LY2835219 in Japanese Participants With Advanced Cancer

A Phase 1 Study of LY2835219 in Japanese Patients With Advanced Cancer

DLT is defined as an adverse event between Day -3 and Day 29 of Cycle 1 that is possibly related to the study drug and fulfills any one of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

Maximum plasma concentration on Day -3 and Day 28 of Cycle 1.

AUC on Day -3 and Day 28 of Cycle 1 are AUC from time zero to infinity \[AUC(0-∞)\] and AUC during one dosing interval at steady state (AUCτ,ss), respectively.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions.

All participants who received at least one dose of study drug.

100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.

Cohort 1 - 100 mg Abemaciclib

Cohort 2 - 150 mg Abemaciclib

Cohort 3 - 200 mg Abemaciclib

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Japan

Region of Enrollment

Chief Medical Officer

All participants who received at least one dose of study drug and took at least 75% of planned dose in Cycle 1 or experienced a DLT in Cycle 1.

Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT)

Cycle 1 Day -3

Cycle 1 Day 28

All participants who received at least one dose of study drug and had evaluable data for Cmax.

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib

AUC(0-∞)

AUCτ,ss (n=2,2,5)

All participants who received at least one dose of study drug and had evaluable data for AUC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread	NCT02057133	Breast Neoplasm...	LY2835219 Letrozole Anastrozole Tamoxifen Exemestane Everolimus Trastuzumab LY3023414 Fulvestrant Pertuzumab Loperamide Endocrine thera...	18 Years -	Eli Lilly and Company
Study of Abemaciclib in Dedifferentiated Liposarcoma	NCT02846987	Sarcoma Dedifferentiate...	Abemaciclib	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of LY2835219 in Japanese Participants With Advanced Cancer	NCT02014129	Neoplasm Metast... Lymphoma	LY2835219	20 Years -	Eli Lilly and Company
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread	NCT02057133	Breast Neoplasm...	LY2835219 Letrozole Anastrozole Tamoxifen Exemestane Everolimus Trastuzumab LY3023414 Fulvestrant Pertuzumab Loperamide Endocrine thera...	18 Years -	Eli Lilly and Company
A Study of LY2835219 in Japanese Participants With Advanced Cancer	NCT02014129	Neoplasm Metast... Lymphoma	LY2835219	20 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for ly2835219

Every month we try and update this database with for ly2835219 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ly2835219

Every month we try and update this database with for ly2835219 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ly2835219 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.