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

April 25, 2007
November 23, 2010
June 2007
August 2009   (final data collection date for primary outcome measure)
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 ]
To determine response rate of enzastaurin given with chemotherapy in prostate cancer patients when they have taken enzastaurin for a maximum of 3 years
Complete list of historical versions of study NCT00466440 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To assess rate of 3-month PSA level decline of greater than or equal to 30%
  • To assess PSA velocity at 3 months
  • To evaluate efficacy, safety and tissue biomarkers
  • To characterize the pharmacokinetics of enzastaurin
Not Provided
Not Provided
 
A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: enzastaurin
    1125 mg loading dose then 500 mg, oral, daily, until disease progression, toxicity, or maximum 3 years
    Other Name: LY317615
  • 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
  • Experimental: A
    Interventions:
    • Drug: enzastaurin
    • Drug: docetaxel
    • Drug: prednisone
  • Placebo Comparator: B
    Interventions:
    • Drug: placebo
    • Drug: docetaxel
    • Drug: prednisone
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. PubMed PMID: 23435622.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
June 2010
August 2009   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Germany
 
NCT00466440
11311, H6Q-MC-S032
Yes
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
November 2010

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