Phase 2
Completed N=28
Enzastaurin for Patients With Metastatic Colorectal Cancer
Colonic Neoplasms
Source: ClinicalTrials.gov NCT00192114 ↗
Enrolled (actual)
28
Serious AEs
14.3%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants With Progression Free Survival (PFS) at 6 Months — 27.50 percentage of participants
Summary
Enzastaurin given daily to participants with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression Free Survival (PFS) at 6 Months |
27.50 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] |
— | — |
| SECONDARY Overall Survival (OS) |
23.38 | — |
| SECONDARY Progression Free Survival (PFS) |
1.89 | — |
| SECONDARY Duration of Stable Disease (SD) |
6.13 | — |
| SECONDARY Time to Treatment Response |
— | — |
| SECONDARY Duration of Complete Response (CR) or Partial Response (PR) (Duration of Response) |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) or Who Died |
4; 22; 2; 1 | — |
| SECONDARY Change From Baseline in QTc Interval |
2.07; 7.30 | — |
| SECONDARY Pharmacokinetics-Minimum Observed Concentration (Cmin) of Total Analytes |
2180; 1723; 1374 | — |
| SECONDARY Change From Baseline in Carcinoembryonic Antigen (CEA) Response at Each Cycle |
0.20; 0.30; 0.90; 0.80; 0.80; 0.35 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosed with colorectal cancer that is advanced or metastatic (has spread to other parts of the body); able to visit the doctor's office every 28 days for at least 6 months; able to swallow tablets
Exclusion Criteria
- women cannot be pregnant or breastfeeding; no history of significant heart disease or any other significant medical problems as determined by the participant's physician
Data sourced from ClinicalTrials.gov (NCT00192114). 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.