Phase 2
Completed N=108
A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients
Source: ClinicalTrials.gov NCT00466440 ↗Enrolled (actual)
108
Serious AEs
37.3%
Results posted
Nov 2020
Primary outcomePrimary: Part 2: Percentage of Participants With Objective Tumor Response (Response Rate) — 15.2; 15.0 percentage of participants — p=1.0000
Summary
The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 2: Percentage of Participants With Objective Tumor Response (Response Rate) |
15.2; 15.0 | 1.0000 |
| SECONDARY Percentage of Participants Exhibiting a Decline in Prostate-Specific Androgen (PSA) From Baseline ≥30% Within First 3 Months of Treatment |
69.2; 60.9; 72.5 | 0.3606 |
| SECONDARY Prostate-Specific Androgen (PSA) Velocity at 2 Months |
-0.56; -0.29; -0.55 | 0.0720 |
| SECONDARY Prostate-Specific Androgen (PSA) Velocity at 3 Months |
-0.45; -0.30; -0.45 | 0.1697 |
| SECONDARY Part 2: Progression Free Survival (PFS) |
229; 213 | 0.5240 |
| SECONDARY Part 2: Overall Survival (OS) |
462; 448 | 0.4407 |
| SECONDARY Part 2: Duration of Response |
231; 201 | 0.3449 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
8; 16; 14; 14; 47; 41 | — |
| SECONDARY Part I: Pharmacokinetic (PK) Parameter: Maximum Observed Drug Concentration During a Dosing Interval at Steady State (Cmax,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020) |
870; 778; 664; 667; 1540; 1450 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020) |
12900; 13100; 20800; 15200; 15700; 24800 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Docetaxel |
2230; 1840 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Docetaxel |
2350; 1750 | — |
| SECONDARY Tumor Markers |
— | — |
Eligibility Criteria
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.
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.
Data sourced from ClinicalTrials.gov (NCT00466440). 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.