Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer
NCT ID: NCT00530621
Last Updated: 2020-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2007-09-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pemetrexed + Enzastaurin
enzastaurin
1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression
pemetrexed
500 milligrams per square meter (mg/m\^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
Pemetrexed + Placebo
placebo
oral, daily
pemetrexed
500 milligrams per square meter (mg/m\^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
Interventions
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enzastaurin
1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression
placebo
oral, daily
pemetrexed
500 milligrams per square meter (mg/m\^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants 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
* Previous treatment with enzastaurin or pemetrexed.
* Concurrent administration of any other antitumor therapy.
* Inability to swallow tablets.
* Pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Fayetteville, Arkansas, 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.
Lancaster, California, United States
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Los Angeles, California, United States
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Tampa, Florida, United States
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Wichita, Kansas, United States
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Scarborough, Maine, United States
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Dayton, Ohio, United States
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Memphis, Tennessee, United States
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Fort Worth, Texas, United States
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Richardson, Texas, United States
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Grenoble, , France
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Marseille, , France
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Saint-Herblain, , France
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Toulouse, , France
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Villejuif, , France
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Cologne, , Germany
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Gauting, , Germany
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Großhansdorf, , Germany
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Aviano, , Italy
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Genova, , Italy
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Orbassano, , Italy
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Seoul, , South Korea
Countries
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Other Identifiers
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H6Q-MC-JCBT
Identifier Type: OTHER
Identifier Source: secondary_id
9820
Identifier Type: -
Identifier Source: org_study_id
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