Clinical trial NCT00105092: Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer.
Official title: A Phase II Evaluation of Oral Enzastaurin HCl in Second-and Third- Line Treatment of Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
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 outcomes:
measure: To evaluate the pharmacokinetics of enzastaurin using sparse sampling methodology in this population
measure: To assess the QTc interval at anticipated steady state levels of enzastaurin (centrally collected 12-lead ECG on Day 1 of Cycle 2)
measure: To estimate the objective response rate (complete response [CR] and partial response [PR])
measure: 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)
measure: To evaluate the safety of enzastaurin in this patient population
measure: To assess PKCb expression by immunohistochemistry in readily available tumors from patients
measure: To evaluate enzastaurin's effect on patients' symptoms, functioning, and health-related quality of life using validated patient questionnaires
measure: To explore biomarkers relevant to tumor progression and PKCb signaling
Other outcomes:
Locations:
city: Tampa
country: United States
facility: 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.
state: Florida
city: Nashville
country: United States
facility: 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.
state: Tennessee
city: Houston
country: United States
facility: 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.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: