A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00466440
First received: April 25, 2007
Last updated: November 23, 2010
Last verified: November 2010
  Purpose

The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.


Condition Intervention Phase
Prostate Cancer
Drug: enzastaurin
Drug: placebo
Drug: docetaxel
Drug: prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study With and Without Enzastaurin in Combination With Docetaxel and Prednisone, Followed By Enzastaurin Maintenance as First-Line Treatment in Hormone Refractory Metastatic Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To determine response rate of enzastaurin given with chemotherapy in prostate cancer patients when they have taken enzastaurin for a maximum of 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess rate of PSA level decline of greater than or equal to 30% [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Adverse events and safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics of enzastaurin [ Time Frame: cycle 1, cycle 2 ] [ Designated as safety issue: No ]
  • Assess tumor biomarkers [ Time Frame: baseline, cycle 2, at 36 months ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression, toxicity, or maximum 3 years
Other Name: LY317615
Drug: docetaxel
75 mg/m2, IV, q 21 days, six 21 day cycles, maximum 10 cycles
Drug: prednisone
5 mg, oral, BID, six 21 day cycles
Placebo Comparator: B Drug: placebo
oral, daily
Drug: docetaxel
75 mg/m2, IV, q 21 days, six 21 day cycles, maximum 10 cycles
Drug: prednisone
5 mg, oral, BID, six 21 day cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You are at least 18 years old.
  • 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 are unable to swallow pills.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466440

  Hide Study Locations
Locations
United States, California
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, 92835
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Los Angeles, California, United States, 90093
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Northridge, California, United States, 91328
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Redondo Beach, California, United States, 90277
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Santa Barbara, California, United States, 93105
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Santa Maria, California, United States, 93454
United States, Florida
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Miami, Florida, United States, 33179
United States, Illinois
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Chicago, Illinois, United States, 60637
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Harvey, Illinois, United States, 60426
United States, Minnesota
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Minneapolis, Minnesota, United States, 55404
United States, Missouri
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Columbia, Missouri, United States, 65201
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Kansas City, Missouri, United States, 64128
United States, Montana
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Billings, Montana, United States, 59101
United States, Nevada
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Henderson, Nevada, United States, 89169
United States, New Mexico
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Las Cruces, New Mexico, United States, 88011
United States, North Carolina
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Raleigh, North Carolina, United States, 27607
United States, Ohio
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Cleveland, Ohio, United States, 44195
United States, Tennessee
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Memphis, Tennessee, United States, 38138
United States, Texas
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Dallas, Texas, United States, 75246
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The Woodlands, Texas, United States, 77380
United States, Virginia
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Newport News, Virginia, United States, 23606
United States, Washington
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Vancouver, Washington, United States, 98684
Germany
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Erlangen, Germany, 91054
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Hamburg, Germany, 22399
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Mannheim, Germany, 68163
Italy
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Como, Italy, 22100
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Orbassano, Italy, 10043
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San Sisto, Italy, 06156
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00466440     History of Changes
Other Study ID Numbers: 11311, H6Q-MC-S032
Study First Received: April 25, 2007
Last Updated: November 23, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 28, 2014