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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00466440
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : November 29, 2010
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: enzastaurin Drug: placebo Drug: docetaxel Drug: prednisone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Prednisone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To assess rate of PSA level decline of greater than or equal to 30% [ Time Frame: 3 months ]
  2. Progression free survival [ Time Frame: baseline to measured progressive disease ]
  3. Adverse events and safety [ Time Frame: every cycle ]
  4. To characterize the pharmacokinetics of enzastaurin [ Time Frame: cycle 1, cycle 2 ]
  5. Assess tumor biomarkers [ Time Frame: baseline, cycle 2, at 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00466440

  Show 28 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00466440     History of Changes
Other Study ID Numbers: 11311
H6Q-MC-S032 ( Other Identifier: Eli Lilly and Company )
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: November 29, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal