500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity

enzastaurin

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 will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public.

The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.

An Open Label Study of Oral Enzastaurin in Participants With Cancer

An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies

Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.

Time to disease progression was defined as the time in months from study enrollment to the first date of progressive disease. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease was defined as having at least a 20% increase in sum of the longest diameter of target lesions. Time to disease progression was censored at the date of the last follow-up for participants who did not experience progressive disease, death, or their disease status was unknown.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response was defined as the disappearance of all target lesions. Partial Response was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease was defined as having at least a 20% increase in sum of longest diameter of target lesions. Stable Disease was defined as small changes that did not meet the above criteria. Also, reported were unknown and missing responses. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100.

Eli Lilly and Company

Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.

Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.

Enzastaurin

Age, Continuous

Sex: Female, Male

Caucasian

Black or African American

Race/Ethnicity, Customized

United States

France

Region of Enrollment

Stage I

Stage II

Stage IIA

Stage IIB

Stage IIC

Stage III

Stage IV

Disease stage describes how big the tumor is and how far it has spread from the site of origin. Stages ranged from I (cancer is small and hasn't spread to the lymph nodes) to IV (cancer has spread throughout the body). Stage II has localized growth with no metastasis and is further differentiated based on the tumor size by Stage IIA (smaller) to Stage IIC (larger).

Disease Stage at Initial Pathological Diagnosis

Metastatic

Locally Advanced

Other (Unspecified Cancer Diagnosis)

Initial Pathological Diagnosis

ECOG performance status was used to classify participants according to their functional impairment. Score 0 = fully active, able to carry on all pre-disease performance without restriction. Score 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work. Score 2 = ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

Eastern Cooperative Oncology Group (ECOG) Performance Status Score

All enrolled participants who received at least 1 dose of enzastaurin.

Chief Medical Officer

SAEs

Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs

All enrolled participants who received at least 1 dose of enzastaurin. Two (2) participants were censored.

Spots Global Cancer Trial Database for An Open Label Study of Oral Enzastaurin in Participants With Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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