A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients
NCT ID: NCT00466440
Last Updated: 2020-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2007-06-30
2010-06-30
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
QUADRUPLE
Study Groups
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docetaxel + prednisone + enzastaurin
Regimen A: docetaxel 75 milligrams per square meter (mg/m\^2), intravenous (IV) is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 milligrams (mg) oral (po), twice daily (BID) every day. In Cycle 1, enzastaurin is given as a loading dose of 1125 mg on the day prior to docetaxel and prednisone therapy, followed by enzastaurin 500 mg po, daily (QD) for the remaining Period 2 (chemotherapy) and Period 3 (maintenance).
enzastaurin
1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years
docetaxel
75 mg/m\^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles
prednisone
5 mg po BID, six 21-day cycles
docetaxel + prednisone + placebo
Regimen B: docetaxel 75 mg/m\^2, IV is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po, BID every day. In Cycle 1, placebo is given as a loading dose on the day prior to docetaxel and prednisone therapy, followed by po, QD placebo for the remaining Period 2 (chemotherapy) and Period 3 (maintenance), until unblinding.
placebo
Loading dose, then po QD until unblinding
docetaxel + prednisone + enzastaurin (modified Regimen A)
Modified Regimen A, including pharmacokinetic (PK) characterization: Participants were treated with a modified investigational regimen with no dose escalation: docetaxel 75 mg/m2, IV was administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po, BID every day. In Cycle 1, enzastaurin was given as a loading dose of 1125 mg starting on Day 4, followed by enzastaurin 500 mg po, QD for the remaining Period 2 (chemotherapy) and Period 3 (maintenance).
enzastaurin
1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years
docetaxel
75 mg/m\^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles
prednisone
5 mg po BID, six 21-day cycles
Interventions
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enzastaurin
1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years
placebo
Loading dose, then po QD until unblinding
docetaxel
75 mg/m\^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles
prednisone
5 mg po BID, six 21-day cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* You live close enough to the doctor's office to attend all of your required visits.
* You have not been treated with chemotherapy for your prostate cancer.
* Your organs must be functioning properly.
Exclusion Criteria
* You have another serious illness besides your prostate cancer.
* You have taken another experimental drug within the last 30 days.
* You have a serious heart condition.
* You are receiving another anti-cancer therapy.
18 Years
MALE
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.
Fullerton, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Redondo Beach, California, United States
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Santa Barbara, California, United States
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Santa Maria, California, United States
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Miami, Florida, United States
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Chicago, Illinois, United States
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Harvey, Illinois, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Billings, Montana, United States
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Henderson, Nevada, United States
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Las Cruces, New Mexico, United States
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Raleigh, North Carolina, United States
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Cleveland, Ohio, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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The Woodlands, Texas, United States
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Newport News, Virginia, United States
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Vancouver, Washington, United States
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Erlangen, , Germany
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Hamburg, , Germany
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Mannheim, , Germany
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Como, , Italy
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Orbassano, , Italy
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San Sisto, , Italy
Countries
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References
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Dreicer R, Garcia J, Rini B, Vogelzang N, Srinivas S, Somer B, Shi P, Kania M, Raghavan D. A randomized, double-blind, placebo-controlled, Phase II study with and without enzastaurin in combination with docetaxel-based chemotherapy in patients with castration-resistant metastatic prostate cancer. Invest New Drugs. 2013 Aug;31(4):1044-50. doi: 10.1007/s10637-013-9940-0. Epub 2013 Feb 24.
Other Identifiers
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H6Q-MC-S032
Identifier Type: OTHER
Identifier Source: secondary_id
11311
Identifier Type: -
Identifier Source: org_study_id