A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
18 Years
N/A
Both
Non-small Cell Lung Cancer
Trial Information
A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Inclusion Criteria:
- Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease
which cannot be cured.
- Patients must have disease which progressed after 1 prior systemic cytotoxic
chemotherapy regimen for advanced disease.
- At least 1 measurable lesion.
- Must have stopped all previous systemic therapies for cancer for at least 2 weeks
prior to enrollment.
- Must be able to follow study guidelines and be able to show up for appointments.
Exclusion Criteria:
- Treatment within the last 30 days with a drug that has not received regulatory
approval for any indication at the time of study entry.
- Previous treatment with enzastaurin or pemetrexed.
- Concurrent administration of any other antitumor therapy.
- Inability to swallow tablets
- Pregnant or breastfeeding
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To compare pemetrexed plus enzastaurin versus pemetrexed plus placebo in terms of the progression-free survival time (PFS) of patients receiving second-line therapy for the treatment of locally advanced or metastatic NSCLC.
Outcome Time Frame:
baseline to measured progressive disease
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
9820
NCT ID:
NCT00530621
Start Date:
September 2007
Completion Date:
October 2008
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | 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. | Greenbrae, California 94904 |
| 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. | Jacksonville, Florida 32256 |
| 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. | Overland Park, Kansas 66210 |
| 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. | Cincinnati, Ohio 45267 |
| 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. | Memphis, Tennessee 38138 |
| 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. | Bedford, Texas 76022 |
| 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. | Little Rock, Arkansas 72205 |
| 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. | Scarborough, Maine 04074 |
