Phase 2 Trial of Enzastaurin in Prostate Cancer in Patients Who Have Had Hormonal and Chemotherapy

Overview

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

Full Title of Study: “Phase 2 Trial Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation and (2) After First-Line Cytotoxic Chemotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2009

Interventions

  • Drug: enzastaurin
    • 1125 mg loading dose then 500 mg, oral, daily, 28 day cycles until disease progression, unacceptable toxicity or 3 years

Arms, Groups and Cohorts

  • Experimental: A

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Chief Medical Officer, Eli Lilly
  • Overall Official(s)
    • 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), Study Director, Eli Lilly and Company

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