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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00105092

Enrollment

Registered

2005-03-07

Start date

2005-03-31

Completion date

2007-02-28

Last updated

2007-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Carcinoma

Brief summary

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

Interventions

DRUGEnzastaurin HCL

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 pharmacokinetics of enzastaurin using sparse sampling methodology in this 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	—
To evaluate the safety of enzastaurin in this patient population	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026