Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00267020
Last Updated: 2020-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2005-12-31
2008-05-31
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
NONE
Study Groups
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Enzastaurin+Gemcitabine
enzastaurin
1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles
gemcitabine
1000 milligrams/square meter (mg/m\^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles
Gemcitabine
gemcitabine
1000 milligrams/square meter (mg/m\^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles
Interventions
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enzastaurin
1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles
gemcitabine
1000 milligrams/square meter (mg/m\^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pretreatment tumor specimen must be available.
* No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy.
* Prior radiation allowed.
* Ability to stop some types of anti-seizure medicines within 14 days of enrollment.
Exclusion Criteria
* Central Nervous System (CNS) metastases.
* Inability to swallow tablets.
* 10% or greater weight loss over the 6 weeks before study entry.
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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Dallas, Texas, United States
Countries
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References
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Yount S, Cella D, Webster K, Heffernan N, Chang C, Odom L, van Gool R. Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: the FACT Hepatobiliary Symptom Index. J Pain Symptom Manage. 2002 Jul;24(1):32-44. doi: 10.1016/s0885-3924(02)00422-0.
Other Identifiers
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H6Q-US-S002
Identifier Type: OTHER
Identifier Source: secondary_id
10463
Identifier Type: -
Identifier Source: org_study_id
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