Phase 2
Completed N=73
Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy
Source: ClinicalTrials.gov NCT00428714 ↗Enrolled (actual)
73
Serious AEs
19.2%
Results posted
Nov 2020
Primary outcomePrimary: Cohort 1 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate) — 1 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate) |
1 | — |
| PRIMARY Cohort 2 - Progression-free Survival (PFS)-Overall |
11.0 | — |
| SECONDARY Cohort 1 - Number of Participants With a 3-month PSA Level Decline of Greater Than or Equal to 30% |
1 | — |
| SECONDARY Cohort 1 - PSA Velocity |
0.10003; 0.06289 | — |
| SECONDARY Cohort 1 - Progression-free Survival (PFS)-Overall |
12 | — |
| SECONDARY Cohort 1 - Duration of Response |
27.9 | — |
| SECONDARY Cohort 2 - 3-month PSA Level Decline of Greater Than or Equal to 30% |
— | — |
| SECONDARY Cohort 2 - PSA Velocity |
0.30297; 0.26702 | — |
| SECONDARY Cohort 2 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate) |
— | — |
| SECONDARY Cohort 2 - Percentage of Participants With Progression Free Survival (PFS) at 6 Months and 12 Months |
3.0; 0.0 | — |
| SECONDARY Cohort 2 - Overall Survival |
NA | — |
| SECONDARY Cohort 2 - Duration of Response |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00428714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.