Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle.

Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.

LY2584702

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)

The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.

A Study of LY2584702 in Solid Tumors

A Phase 1 Study of LY2584702 in Japanese Patients With Solid Tumors

A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count \<50.0 x 10\^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count \<0.5 x 10\^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.

Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is ≥30% decrease in sum of longest diameter of target lesions.

AUC of single dose is AUC(0-12hours), and AUC of multiple doses is AUC during one dosing interval at steady state.

Eli Lilly and Company

50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle

50 mg LY2584702

75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle

75 mg LY2584702

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Japan

Region of Enrollment

Adenocarcinoma, Colon

Adenocarcinoma, Esophageal

Adenocarcinoma, Gastric

Carcinoid Tumor, not otherwise specified (NOS)

Carcinoma, Esophagus

Gastrointestinal Stromal Tumors

Pathological Diagnosis

0 - Fully active

1 - Ambulatory, restricted strenuous activity

Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

Eastern Cooperative Oncology Group (ECOG) Performance Status Prior to Cycle 1

Chief Medical Officer

All participants who were enrolled in the study.

Number of Participants With Clinically Significant Effects

Number of Participants With Tumor Response

50 milligram (mg) LY2584702 single oral dose on Day 1

50 mg LY2584702 Single Dose

75 mg LY2584702 single oral dose on Day 1

75 mg LY2584702 Single Dose

50 mg LY2584702 oral doses twice daily for a 28-day cycle

50 mg LY2584702 Multiple Doses

75 mg LY2584702 oral doses twice daily for a 28-day cycle

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