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

Non-Small-Cell Lung Carcinoma Clinical Trial

Official title:

A Phase II Evaluation of Oral Enzastaurin HCl in Second-and Third- Line Treatment of Patients With Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105092
• Other study ID #: 8670
• Secondary ID: H6Q-MC-JCAQ
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2005
• Last updated: April 27, 2007
• Start date: March 2005
• Est. completion date: February 2007

Study information

• Verified date: April 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• Enzastaurin HCL

Locations

Country	Name	City	State
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	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.	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the pharmacokinetics of enzastaurin using sparse sampling methodology in this population
Secondary	To assess the QTc interval at anticipated steady state levels of enzastaurin (centrally collected 12-lead ECG on Day 1 of Cycle 2)
Secondary	To estimate the objective response rate (complete response [CR] and partial response [PR])
Secondary	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)
Secondary	To evaluate the safety of enzastaurin in this patient population
Secondary	To assess PKCb expression by immunohistochemistry in readily available tumors from patients
Secondary	To evaluate enzastaurin's effect on patients' symptoms, functioning, and health-related quality of life using validated patient questionnaires
Secondary	To explore biomarkers relevant to tumor progression and PKCb signaling

External Links

•   Lilly Clinical Trial Registry