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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
Est. primary completion date
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


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
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