Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY317615 · 1 trial · 1 indication
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.
LY317615 is an investigational small molecule being studied for the treatment of Non-Hodgkin's Lymphoma, specifically in patients with relapsed or refractory diffuse large B-cell lymphomas. It is being developed by Eli Lilly and Company and is currently in Phase 2 clinical development.
LY317615 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 2 clinical trials for the treatment of Non-Hodgkin's Lymphoma.
LY317615 is in Phase 2 clinical development. It has completed one Phase 2 trial for Non-Hodgkin's Lymphoma, and it is not yet approved by regulatory authorities. The drug remains investigational and is being studied for safety and efficacy in patients with relapsed or refractory diffuse large B-cell lymphomas.
LY317615 has been studied in one completed clinical trial, registered as NCT00042666. This Phase 2 study evaluated oral LY317615 in patients with relapsed or refractory diffuse large B-cell lymphomas, a type of Non-Hodgkin's Lymphoma. The trial enrolled 55 participants in the United States.
LY317615 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Non-Hodgkin's Lymphoma. The completed Phase 2 trial, NCT00042666, has finished, but the drug has not yet received regulatory approval and remains under clinical investigation.