Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2835219 · 6 trials · 4 indications
Number of participants with one or more drug-related adverse events
DLT is defined as an adverse event between Day -3 and Day 29 of Cycle 1 that is possibly related to the study drug and fulfills any one of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
The percentage of the total radioactive dose administered that was excreted in urine or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) \* 100.
| Arm | Type | Description |
|---|---|---|
| 200 mg LY2835219 | EXPERIMENTAL | 200 mg LY2835219 administered orally on day 1. |
| 0.4 mg ¹³C₈-LY2835219 | EXPERIMENTAL | 0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose. |
| LY2835219 | EXPERIMENTAL | Single oral dose of LY2835219 |
| LY2835219 + Rifampin | EXPERIMENTAL | Single oral dose of LY2835219 with rifampin orally, once daily for 14 days |
| LY2835219 + Letrozole | EXPERIMENTAL | LY2835219 administered orally. Letrozole administered orally. This arm is closed to enrollment. |
| LY2835219 + Anastrozole | EXPERIMENTAL | LY2835219 administered orally. Anastrozole administered orally. This arm is closed to enrollment. |
| LY2835219 + Tamoxifen | EXPERIMENTAL | LY2835219 administered orally. Tamoxifen administered orally. This arm is closed to enrollment. |
| LY2835219 + Exemestane | EXPERIMENTAL | LY2835219 administered orally. Exemestane administered orally. This arm is closed to enrollment. |
| LY2835219 + Exemestane + Everolimus Dose Escalation | EXPERIMENTAL | LY2835219 administered orally. Exemestane administered orally. Everolimus administered orally. This arm is closed to enrollment. |
| LY2835219 + Exemestane + Everolimus Dose Expansion | EXPERIMENTAL | LY2835219 administered orally. Exemestane administered orally. Everolimus administered orally. This arm is closed to enrollment. |
| LY2835219+ Trastuzumab Dose Escalation | EXPERIMENTAL | LY2835219 administered orally. Trastuzumab administered intravenously (IV) infusion. This arm is closed to enrollment. |
| LY2835219+ Trastuzumab Dose Expansion | EXPERIMENTAL | LY2835219 administered orally. Trastuzumab administered IV infusion. This arm is closed to enrollment. |
| LY3023414 + LY2835219 + Fulvestrant Dose Escalation | EXPERIMENTAL | LY3023414 administered orally. LY2835219 administered orally. Fulvestrant administered intramuscularly (IM). |
| LY3023414 + LY2835219 + Fulvestrant Dose Expansion | EXPERIMENTAL | LY3023414 administered orally. LY2835219 administered orally. Fulvestrant administered IM. |
| LY2835219 +Trastuzumab +Pertuzumab +Loperamide Dose Escalation | EXPERIMENTAL | LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion. |
| LY2835219 +Trastuzumab + Pertuzumab +Loperamide Dose Expansion | EXPERIMENTAL | Hormone Receptor Negative (HR-): LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion. Hormone Receptor Positive (HR+): LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion. Endocrine therapy administered orally. |
| LY2835219 + Endocrine Therapy | EXPERIMENTAL | LY2835219 administered orally. Ongoing endocrine therapy administered orally. |
| LY2835219 Standard | EXPERIMENTAL | Single oral dose of LY2835219 given with a standard meal in one of three study periods. |
| LY2835219 Fasted | EXPERIMENTAL | Single oral dose of LY2835219 given with no food in one of three periods. |
| LY2835219 High-Fat | EXPERIMENTAL | Single oral dose of LY2835219 given with a high fat meal in one of three periods. |
| Cohort 1 - 100 mg Abemaciclib | EXPERIMENTAL | 100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| Cohort 2 - 150 mg Abemaciclib | EXPERIMENTAL | 150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| Cohort 3 - 200 mg Abemaciclib | EXPERIMENTAL | 200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| [^14C]-LY2835219 | EXPERIMENTAL | Single 150 milligram (mg) oral dose solution of LY2835219 containing 5 micro-curies of (µCi) \[\^14C\] labeled drug |
| Name | Type | Description |
|---|---|---|
| LY2835219 | DRUG | Administered orally |
| ¹³C₈-LY2835219 | DRUG | Administered IV |
| Rifampin | DRUG | Administered orally |
| Letrozole | DRUG | Administered orally. |
| Anastrozole | DRUG | Administered orally. |
| Tamoxifen | DRUG | Administered orally. |
| Exemestane | DRUG | Administered orally. |
| Everolimus | DRUG | Administered orally. |
| Trastuzumab | DRUG | Administered IV infusion. |
| LY3023414 | DRUG | Administered orally. |
| Fulvestrant | DRUG | Administered IM. |
| Pertuzumab | DRUG | Administered IV infusion. |
| Loperamide | DRUG | Administered orally. |
| Endocrine therapy | DRUG | Endocrine therapy administered orally. |
| [^14C]-LY2835219 | DRUG | Administered as oral solution |
Inclusion Criteria: * Overtly healthy sterile males or surgically sterile females or postmenopausal females * Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2) * Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site. *...
LY2835219 is an investigational small molecule being studied for use in breast neoplasms, neoplasm metastasis, and healthy volunteers. It is in Phase 1 clinical development. The drug is not approved and remains under investigation for these oncology-related conditions.
LY2835219 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company is conducting Phase 1 clinical trials with this investigational small molecule in oncology and healthy volunteer studies.
LY2835219 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in early-stage trials. All four clinical trials listed for LY2835219 are Phase 1 studies, with one currently active and four completed.
LY2835219 has four Phase 1 clinical trials: NCT01913314, NCT02059148, NCT02256267, and NCT02327143. These studies enroll healthy volunteers in the United States and United Kingdom, with a total enrollment of 198 participants. One trial is active, and four are completed.
LY2835219 is the investigational code name for the drug also known as abemaciclib. It is being developed by Eli Lilly and Company for oncology indications including breast neoplasms and neoplasm metastasis. The drug is in Phase 1 clinical trials.