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

April 27, 2007 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • 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.
    • Tennessee
      • 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.
    • Texas
      • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

March 4, 2005

First Submitted That Met QC Criteria

March 4, 2005

First Posted (Estimate)

March 7, 2005

Study Record Updates

Last Update Posted (Estimate)

May 1, 2007

Last Update Submitted That Met QC Criteria

April 27, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8670
  • H6Q-MC-JCAQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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