Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2181308 · 3 trials · 3 indications
The tumor size was defined as the sum of the longest diameters for the target lesions. The sum of lesion diameters was calculated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. The log ratio of tumor size at the end of Cycle 2 to tumor size at baseline was calculated for each participant.
Data are presented as number of participants who experienced serious adverse events (SAE) and possibly drug-related treatment-emergent adverse events (TEAE) during the study including the 21-day follow-up period. A summary of serious adverse events and other nonserious adverse events regardless of causality is located in the Reported Adverse Events section.
PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug.
Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.
| Arm | Type | Description |
|---|---|---|
| LY2181308 + Docetaxel | EXPERIMENTAL | LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met. Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met. |
| Docetaxel | ACTIVE_COMPARATOR | Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met. |
| LY2181308 sodium, idarubicin, cytarabine | EXPERIMENTAL | - |
| A: Docetaxel | ACTIVE_COMPARATOR | Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy |
| B: LY2181308 + Docetaxel | EXPERIMENTAL | LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel |
| Name | Type | Description |
|---|---|---|
| Docetaxel | DRUG | Administered intravenously |
| LY2181308 | DRUG | Administered intravenously |
| LY2181308 sodium | DRUG | 750 milligrams (mg) is administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 (28 days) and Days 1, 8, 15, 22 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops. |
| cytarabine | DRUG | 1.5 grams per square meter (g/m²) will be administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops. |
| idarubicin | DRUG | 12 milligrams per square meter (mg/m²) will be administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and on Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops. |
| Prednisone | DRUG | Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy |
Inclusion Criteria: * Participants with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy * Measureable disease as defined by response evaluation criteria in solid t...
LY2181308 is an investigational small molecule being studied for the treatment of non-small cell lung cancer, acute myeloid leukemia, and prostate cancer. It has been evaluated in Phase 2 clinical trials for these oncology indications.
LY2181308 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY.
LY2181308 is in Phase 2 clinical development. It has completed Phase 2 trials in non-small cell lung cancer, acute myeloid leukemia, and prostate cancer. It is investigational and not yet approved by regulatory authorities.
LY2181308 has completed three Phase 2 trials: NCT00620321 in relapsed or refractory acute myeloid leukemia, NCT00642018 in hormone refractory prostate cancer, and NCT01107444 in non-small cell lung cancer. All trials are completed.
LY2181308 is also known as LY2181308 sodium. The clinical trial NCT00620321 specifically studied LY2181308 sodium in patients with relapsed or refractory acute myeloid leukemia.