Phase 2
Completed N=60
Oral Enzastaurin in Participants With Relapsed Mantle Cell Lymphoma
Source: ClinicalTrials.gov NCT00088205 ↗Enrolled (actual)
60
Serious AEs
33.3%
Results posted
Jul 2020
Primary outcomePrimary: Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles — 35.6 percentage of participants
Summary
The purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles |
35.6 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) Plus Unconfirmed Complete Response (CRu) Plus Partial Response (PR) (Objective Response Rate) |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
1.97 | — |
| SECONDARY Overall Survival (OS) |
22.01 | — |
| SECONDARY Duration of CR, CRu, PR or Stable Disease (SD) [Duration of Overall Response] |
5.55 | — |
| SECONDARY Time to New Treatment |
3.52 | — |
| SECONDARY Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4) |
22.45; 22.06; 22.15; 21.6; 21.13; 20.32 | — |
| SECONDARY Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status) |
0.70; 0.76; 0.74; 0.68 | — |
| SECONDARY Number of Participants With Protein Kinase C Beta (PKCβ) Expression by Immunohistochemistry (IHC) Staining |
14; 4 | — |
| SECONDARY Number of Participants With High Ki-67 Expression by IHC Staining |
4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin) |
20; 54; 4; 0; 6 | — |
| SECONDARY Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes) |
627; 1160 | — |
Eligibility Criteria
Inclusion Criteria
- Mantle cell lymphoma
- Previous treatment for mantle cell lymphoma
- Previously relapsed mantle cell lymphoma with no more than 4 chemotherapy regimens.
- Have discontinued all previous therapies for cancer, except corticosteroids up to 25 milligrams per day (mg/day)
- Adequate organ function
Exclusion Criteria
- Inability to swallow tablets
- Must not have significant heart problems
Data sourced from ClinicalTrials.gov (NCT00088205). 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.