CClinicalTrials.gg
CompletedNCT00105092Updated May 1, 2007

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

A Phase 2 interventional study of Enzastaurin HCL in Non-Small-Cell Lung Carcinoma, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-05-01.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Non-Small-Cell Lung Carcinoma
03

In context

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's enrollment of 50 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 141 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants

Interventions

  • DrugEnzastaurin HCL
06

What researchers measure

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

07

Study locations

3 sites
  • 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
  • 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.
    Houston, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00105092
Lead sponsor
Eli Lilly and Company
First posted
Mar 7, 2005
Start date
Mar 2005
Completion
Feb 2007
Last update
May 1, 2007

Study contacts

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)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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