Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare 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.

LY2835219

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.

Eli Lilly and Company

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.

Spots Global Cancer Trial Database for A Study of LY2835219 in Japanese Participants With Advanced Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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