Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00042666 | A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas. | PHASE2 | COMPLETED | 55 | — | — | Jun 1, 2002 | Sep 1, 2008 | Aug 10, 2020 | 3 | United States |
Clinical Response Rate in participants with DLBCL was calculated as (number of participants who were progression-free for at least two 28-day cycles \[clinical responder\]) divided by (total number of participants analyzed) multiplied by 100. Progression free survival (PFS) defined as the time from randomization to the first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| LY317615 | EXPERIMENTAL | 500 milligrams (mg), oral, daily (QD), up to six (6) 28-day cycles |
| Name | Type | Description |
|---|---|---|
| LY317615 | DRUG | 500 mg, oral, QD, up to six 28 day cycles |
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.