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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:
ClinicalTrials.gov Identifier:
NCT00428714
First Posted: January 30, 2007
Last Update Posted: August 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose

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


Condition Intervention Phase
Prostate Cancer Drug: enzastaurin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation and (2) After First-Line Cytotoxic Chemotherapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Cohort 1 - Objective Response Rate [ Time Frame: baseline to measured progressive disease ]
  • Cohort 2 - Progression-free Survival [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: January 2007
Study Completion Date: January 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428714


Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States, 90025
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stanford, California, United States, 94305
United States, Connecticut
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New Haven, Connecticut, United States, 06520
United States, Michigan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ann Arbor, Michigan, United States, 48109
United States, Nevada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Las Vegas, Nevada, United States, 89135
United States, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buffalo, New York, United States, 14263
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New York, New York, United States, 10032
United States, Ohio
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lancaster, Pennsylvania, United States, 17605
United States, Tennessee
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis, Tennessee, United States, 38120
United States, Wisconsin
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin, United States, 53792
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00428714     History of Changes
Other Study ID Numbers: 10737
H6Q-MC-S024 ( Other Identifier: Eli Lilly and Company )
First Submitted: January 26, 2007
First Posted: January 30, 2007
Last Update Posted: August 8, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases