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

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00105092

First received: March 4, 2005

Last updated: April 27, 2007

Last verified: April 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

March 4, 2005

Last Updated Date

April 27, 2007

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00105092 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

- 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

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Non-Small-Cell Lung Carcinoma

Intervention ^ICMJE

Drug: Enzastaurin HCL

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00105092

Other Study ID Numbers ^ICMJE

8670, H6Q-MC-JCAQ

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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