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OpenTrials
Completed

NCT Number: NCT00105092

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

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

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Key information

Conditions

Non-Small-Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enzastaurin HCl

Drug

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

  1. To evaluate the pharmacokinetics of enzastaurin using sparse sampling methodology in this population

  2. To assess the QTc interval at anticipated steady state levels of enzastaurin (centrally collected 12-lead ECG on Day 1 of Cycle 2)

  3. To estimate the objective response rate (complete response [CR] and partial response [PR])

  4. 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)

  5. To evaluate the safety of enzastaurin in this patient population

  6. To assess PKCb expression by immunohistochemistry in readily available tumors from patients

  7. To evaluate enzastaurin's effect on patients' symptoms, functioning, and health-related quality of life using validated patient questionnaires

  8. To explore biomarkers relevant to tumor progression and PKCb signaling

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Mar 7, 2005
Registry last updated
May 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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