A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00466440

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: enzastaurin Drug: placebo Drug: docetaxel Drug: prednisone	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Prednisone Enzastaurin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	96
Study Start Date:	June 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: enzastaurin 1125 mg loading dose then 500 mg, oral, daily, until disease progression, toxicity, or maximum 3 years 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
B: Placebo Comparator	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466440

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 40 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11311, H6Q-MC-S032
Study First Received:	April 25, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00466440
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Prednisone
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009