Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer.
Phase 2
Completed
- Conditions
- Non-Small-Cell Lung Carcinoma
- Registration Number
- NCT00105092
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least one prior therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To estimate the objective response rate (complete response [CR] and partial response [PR]) 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 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
Trial Locations
- Locations (1)
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.
🇺🇸Houston, Texas, United States
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.🇺🇸Houston, Texas, United States