Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer.
A Phase II Evaluation of Oral Enzastaurin HCl in Second-and Third- Line Treatment of Patients With Non-Small Cell Lung Cancer
2 other identifiers
interventional
50
1 country
3
Brief Summary
Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least one prior therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2005
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 4, 2005
CompletedFirst Posted
Study publicly available on registry
March 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedMay 1, 2007
April 1, 2007
March 4, 2005
April 27, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
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 (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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.
Nashville, Tennessee, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 4, 2005
First Posted
March 7, 2005
Study Start
March 1, 2005
Study Completion
February 1, 2007
Last Updated
May 1, 2007
Record last verified: 2007-04