Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer.

Phase 2CompletedNCT00105092

Eli Lilly and Company50 enrolled

Overview

Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least one prior therapy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

Enzastaurin HCLDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must be at least 18 years old * Must have been diagnosed with advanced or metastatic non-small cell lung cancer * Must be able to visit the doctor's office every 28 days for 6 months or longer. Exclusion Criteria: * Pregnant or breastfeeding women * Have other significant medical problems as determined by your physician * Are unable to swallow tablets * Have a history of significant heart disease

Locations (3)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Tampa, Florida, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Outcomes

Primary Outcomes

To estimate the rate of progression-free survival at 6 months for patients receiving oral enzastaurin with NSCLC who are eligible for second-or third-line therapy

Secondary Outcomes

To evaluate the pharmacokinetics of enzastaurin using sparse sampling methodology in this population

To assess the QTc interval at anticipated steady state levels of enzastaurin (centrally collected 12-lead ECG on Day 1 of Cycle 2)

To estimate the objective response rate (complete response [CR] and partial response [PR])

To estimate time-to-event variables, such as overall survival time, duration of overall response (up to 1 year), and duration of stable disease (up to 1 year)

To evaluate the safety of enzastaurin in this patient population

To assess PKCb expression by immunohistochemistry in readily available tumors from patients

To evaluate enzastaurin's effect on patients' symptoms, functioning, and health-related quality of life using validated patient questionnaires

To explore biomarkers relevant to tumor progression and PKCb signaling

Data from ClinicalTrials.gov

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