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Phase 2 Trial of Enzastaurin in Prostate Cancer in Patients Who Have Had Hormonal and Chemotherapy

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ClinicalTrials.gov Identifier: NCT00428714
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : August 8, 2011
Information provided by:
Eli Lilly and Company

January 26, 2007
January 30, 2007
August 8, 2011
January 2007
June 2009   (Final data collection date for primary outcome measure)
  • Cohort 1 - Objective Response Rate [ Time Frame: baseline to measured progressive disease ]
  • Cohort 2 - Progression-free Survival [ Time Frame: baseline to measured progressive disease ]
The primary goal is to determine response rates of enzastaurin given to two different cohorts of prostate cancer patients when at least 70% of them come off study or when no patient has been on-study for less than 2 years, whichever occurs first.
Complete list of historical versions of study NCT00428714 on ClinicalTrials.gov Archive Site
  • Cohort 1 - 3-month PSA level decline of greater than or equal to 30% [ Time Frame: baseline to 3 months ]
  • Cohort 1 - PSA Velocity [ Time Frame: baseline, 2 months, 3 months ]
  • Cohort 1 - Progression-free survival [ Time Frame: 24 months ]
  • Cohort 1 - Duration of Response [ Time Frame: time of response to progressive disease ]
  • Cohort 2 - 3-month PSA level decline of greater than or equal to 30% [ Time Frame: baseline to measured progressive disease ]
  • Cohort 2 - PSA Velocity [ Time Frame: baseline, 2 months, 3 months ]
  • Cohort 2 - Objective response rate [ Time Frame: baseline to measured progressive disease ]
  • Cohort 2 - Progression Free Survival [ Time Frame: 6 months, 12 months ]
  • Cohort 2 - Overall survival [ Time Frame: baseline to date of death from any cause ]
  • Cohort 2 - Duration of response [ Time Frame: time of response to progressive disease ]
The secondary goals are to assess rate of 3-month PSA level decline of greater than equal 30%, to assess duration of response, to evaluate the safety and tolerability, to evaluate tissue biomarkers and to characterize the pharmacokinetics of enzastaurin.
Not Provided
Not Provided
Phase 2 Trial of Enzastaurin in Prostate Cancer in Patients Who Have Had Hormonal and Chemotherapy
Phase 2 Trial Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation and (2) After First-Line Cytotoxic Chemotherapy

The purpose is to see how quickly two different types of prostate cancer patients respond when taking enzastaurin.

Cohort 1 - asymptomatic patients with androgen-independent PSA-progressive disease with or without clinical or radiographic evidence of metastatic disease.

Cohort 2 - patients with androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases) with rising PSA, clinical, radiographic disease progression following one prior docetaxel-based regimen

Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, 28 day cycles until disease progression, unacceptable toxicity or 3 years
Other Name: LY317615
Experimental: A
Intervention: Drug: enzastaurin
Dreicer R, Garcia J, Hussain M, Rini B, Vogelzang N, Srinivas S, Somer B, Zhao YD, Kania M, Raghavan D. Oral enzastaurin in prostate cancer: a two-cohort phase II trial in patients with PSA progression in the non-metastatic castrate state and following docetaxel-based chemotherapy for castrate metastatic disease. Invest New Drugs. 2011 Dec;29(6):1441-8. doi: 10.1007/s10637-010-9428-0. Epub 2010 Apr 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2011
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • You are expected to be alive in the 12 weeks.
  • 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 (cohort 1).
  • You have had one prior docetaxel-based chemotherapy regimen (cohort 2).
  • You have evidence of metastatic prostate cancer with bone or soft tissue disease (cohort 2).
  • Your organs must be functioning properly.

Exclusion Criteria:

  • You are unable to swallow pills.
  • You have another 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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
H6Q-MC-S024 ( Other Identifier: Eli Lilly and Company )
Not Provided
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP