Phase 2
N=55
A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.
Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00042666 ↗Enrolled (actual)
55
Serious AEs
38.2%
Results posted
Aug 2020
Primary outcome: Primary: Percentage of Participants With Relapsed or Refractory DLBCL Who Are Progression-Free for at Least 2 Cycles (28-Day Cycles) After Receiving Enzastaurin (LY317615) (Clinical Response Rate) — 21.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY317615 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Relapsed or Refractory DLBCL Who Are Progression-Free for at Least 2 Cycles (28-Day Cycles) After Receiving Enzastaurin (LY317615) (Clinical Response Rate) |
21.8 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate) |
3.64 | — |
| SECONDARY Progression Free Survival (PFS) |
1.51 | — |
| SECONDARY Duration of Overall Response (DOR) |
NA | — |
| SECONDARY Number of Participants With Adverse Events (AEs) or Who Died |
51; 21; 3; 1; 11 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval (AUC0-24,ss) of Enzastaurin and Its Metabolite LY326020 |
14800; 14200 | — |
| SECONDARY PKCβ Expression by IHC in Readily Assessable DLBCL Tumors From Participants |
1; 1; 1 | — |
Summary
This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).
Eligibility Criteria
Inclusion Criteria
- A diagnosis of recurrent or refractory DLBCL.
- Adequate organ functions.
- Able to swallow capsules.
Exclusion Criteria
- More than 3 prior treatments for this disease.
- Serious heart problems.
Data sourced from ClinicalTrials.gov (NCT00042666). 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.