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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2007

Last Updated Date

November 23, 2010

Start Date ^ICMJE

June 2007

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To determine response rate of enzastaurin given with chemotherapy in prostate cancer patients when they have taken enzastaurin for a maximum of 3 years

Change History

Complete list of historical versions of study NCT00466440 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A
Interventions:
- Drug: enzastaurin
- Drug: docetaxel
- Drug: prednisone
Placebo Comparator: B
Interventions:
- Drug: placebo
- Drug: docetaxel
- Drug: prednisone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

101

Completion Date

June 2010

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany, Italy

Administrative Information

NCT Number ^ICMJE

NCT00466440

Other Study ID Numbers ^ICMJE

11311, H6Q-MC-S032

Has Data Monitoring Committee

Yes

Responsible Party

Chief Medical Officer, Eli Lilly

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

November 2010

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

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