Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: enzastaurin
Intervention description: Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose is to see how quickly two different types of prostate cancer participants respond
      when taking enzastaurin.

      Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen
      (PSA)-progressive disease without clinical or radiographic evidence of metastatic disease.

      Cohort 2 - participants 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
    

Eligibility 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).

          -  Must have evidence of androgen-independent PSA-progressive disease without a history
             of or current (as judged by the investigator) clinical or radiographic evidence of
             metastatic disease with castrate levels of testosterone (<50 ng/dL) maintained by
             luteinizing hormone-releasing hormone (LHRH) agonist or bilateral orchiectomy
             following standard anti-androgen withdrawal. NOTE: PSA progression is defined as have
             rising PSA values of <=5 ng/mL (at least 3 measurements 1 week apart) with castrate
             levels of testosterone <50 ng/dL following appropriate antiandrogen withdrawal,
             without evidence of metastases. (cohort 1)

          -  No prior systemic chemotherapy for prostate cancer. No prior chemotherapy for any
             other indication within 2 years of study entry. NOTE: Participants previously treated
             with chemotherapy in the adjuvant/neoadjuvant setting were not be eligible. (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).

          -  Must have evidence of docetaxel-resistant, androgen-independent metastatic prostate
             cancer with bone or soft tissue disease (PSA only participants are not eligible)
             defined as either: clinical, PSA or radiographic disease progression while receiving
             docetaxel-based therapy or PSA and/or radiographic progression at any time after
             completion of a docetaxel-containing regimen with PSA progression defined as a 25%
             increase in PSA from the post docetaxel value or interval progression in known
             metastatic sites of disease or development of new sites of disease on bone scan or
             computed tomography (CT) imaging. Note: Participants who discontinued a
             docetaxel-containing regimen due to toxicity or any other reasons not related to
             disease progression while on treatment, and were not able to complete at least 2
             cycles, were not be eligible. (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.