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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00428714
First received: January 26, 2007
Last updated: August 1, 2011
Last verified: August 2011

January 26, 2007
August 1, 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 ] [ Designated as safety issue: No ]
  • Cohort 2 - Progression-free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Cohort 1 - PSA Velocity [ Time Frame: baseline, 2 months, 3 months ] [ Designated as safety issue: No ]
  • Cohort 1 - Progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Cohort 1 - Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Cohort 2 - 3-month PSA level decline of greater than or equal to 30% [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Cohort 2 - PSA Velocity [ Time Frame: baseline, 2 months, 3 months ] [ Designated as safety issue: No ]
  • Cohort 2 - Objective response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Cohort 2 - Progression Free Survival [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Cohort 2 - Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Cohort 2 - Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Completed
72
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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00428714
10737, H6Q-MC-S024
No
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