Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005403

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005403
  •   2013/11/05
  •   2007/04/25
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00466440  (ClinicalTrials.gov)
  •   11311  (Eli Lilly and Company)
  •   H6Q-MC-S032 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: enzastaurin
  •   Drug: placebo
  •   Drug: docetaxel
  •   Drug: prednisone
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- 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

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Secondary Outcome

- To assess rate of PSA level decline of greater than or equal to 30%; time frame: 3 months
- Progression free survival; time frame: baseline to measured progressive disease
- Adverse events and safety; time frame: every cycle
- To characterize the pharmacokinetics of enzastaurin; time frame: cycle 1, cycle 2
- Assess tumor biomarkers; time frame: baseline, cycle 2, at 36 months

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Countries of Recruitment

  •   United States
  •   Germany
  •   Italy
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2007/06/30
  •   101
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Eli Lilly and Company
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    • Eli Lilly and Company
    • 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) 
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    •   [---]*
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    • Eli Lilly and Company
    • 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) 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/06/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.