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Also known as LY3023414 Reference Fasted, LY3023414 Test Fed, [¹⁴C]-LY3023414
LY3023414 · 5 trials · 9 indications
PFS was defined as the time from randomization until the date of clinical (symptomatic or radiographic) and/or prostate specific antigen (PSA) disease progression per Prostate Cancer Clinical Trials Working Group (PCWG2) or death by any cause regardless of whether the participants withdraws from study drug or receives a subsequent anti-cancer therapy (as determined by the investigator). Participants who have not progressed or died at the time of assessment were censored at the time of the last date of assessment (tumor evaluation or PSA level).
| Arm | Type | Description |
|---|---|---|
| Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD | EXPERIMENTAL | Participants received 200 milligrams (mg) LY3023414 orally twice daily (BID) during the initial week to assess pharmacokinetics (PK). Thereafter, participants received 200 mg of LY3023414 BID in combination with 160 mg of enzalutamide QD beginning Cycle 1 Day 1. A treatment cycle was defined as 28 days. |
| Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD | EXPERIMENTAL | Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD). |
| Part B: Placebo + 160 mg Enzalutamide QD | ACTIVE_COMPARATOR | Participants received placebo in combination with 160 mg enzalutamide QD. |
| LY3023414 Reference Fasted | EXPERIMENTAL | Single oral dose of LY3023414 (Reference) on day one fasting. |
| LY3023414 Test Fasted | EXPERIMENTAL | Single oral dose of LY3023414 (Test) on day one fasting. |
| LY3023414 Test Fed | EXPERIMENTAL | Single oral dose of LY3023414 (Test) on day one after a meal. |
| [¹⁴C]-LY3023414 | EXPERIMENTAL | Single oral dose of \[¹⁴C\]-LY3023414 administered on Day 1 |
| LY3023414 | EXPERIMENTAL | LY3023414 administered orally, twice daily in 21-day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met. |
| Part A: LY3023414 Once Daily | EXPERIMENTAL | LY3023414 administered orally once daily (QD) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation. |
| Part A2: LY3023414 Twice Daily | EXPERIMENTAL | LY3023414 administered orally twice daily (BID) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation. |
| Part B1 : LY3023414 + Midazolam | EXPERIMENTAL | LY3023414 administered orally BID for two 21 day cycles to participants with advanced/metastatic cancer; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A. 0.2 milligrams (mg) midazolam administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15. |
| Part B2: LY3023414 + Fulvestrant | EXPERIMENTAL | LY3023414 administered orally BID for two 28 day cycles to participants with advanced/metastatic breast cancer; participants receiving benefit may continue until disease progression or discontinuation. 500 mg fulvestrant administered IM once every 28 days. |
| Part B3: LY3023414 | EXPERIMENTAL | LY3023414 administered orally BID for two 21 day cycles to participants with malignant mesothelioma; participants receiving benefit may continue until disease progression or discontinuation. |
| Part B4: LY3023414 + pemetrexed/cisplatin | EXPERIMENTAL | LY3023414 administered orally BID for two 21 day cycles to participants with malignant mesothelioma; participants receiving benefit may continue until disease progression or discontinuation. 500 mg/m2 pemetrexed and 75 mg/m2 administered IV once every 21 days. |
| Part B5: LY3023414 | EXPERIMENTAL | LY3023414 administered orally BID for two 21 day cycles to participants with indolent non-Hodgkin's lymphoma; participants receiving benefit may continue until disease progression or discontinuation. |
| Part B6: LY3023414 | EXPERIMENTAL | LY3023414 administered orally BID for two 21 day cycles to participants with squamous NSCLC; participants receiving benefit may continue until disease progression or discontinuation. |
| Part B7: LY3023414 + Abemaciclib + Letrozole | EXPERIMENTAL | LY3023414 administered orally BID with abemaciclib administered orally BID and letrozole administered orally once a day for two 28 day cycles to participants with breast cancer; participants receiving benefit may continue until disease progression or discontinuation. |
| Name | Type | Description |
|---|---|---|
| LY3023414 | DRUG | Administered orally |
| Enzalutamide | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| LY3023414 Reference Fasted | DRUG | Administered Orally |
| LY3023414 Test Fasted | DRUG | Administered Orally |
| LY3023414 Test Fed | DRUG | Administered Orally |
| [¹⁴C]-LY3023414 | DRUG | LY3023414 in solution containing approximately 100 microCi \[¹⁴C\]-LY3023414 |
| Midazolam | DRUG | 0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15. |
| Fulvestrant | DRUG | 500 mg administered IM on Day 1 and Day 15 in cycle 1 and Day 1 every 28 days for additional cycles. |
| Pemetrexed | DRUG | 500 mg/m2 administered IV once on Day 1 every 21 days |
| Cisplatin | DRUG | 75 mg/m2 administered IV once on Day 1 every 21 days |
| Abemaciclib | DRUG | Administered orally |
| Letrozole | DRUG | Administered orally |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate. * Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan. * Prostate cancer progression documented by PSA and/or ra...
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LY3023414 is an investigational small molecule developed by Eli Lilly and Company for advanced cancer, neoplasm, and metastatic prostate cancer. It is also studied in healthy volunteers for formulation and food effect assessments. The drug remains in clinical development and is not approved for any indication.
LY3023414 targets PI3K and mTOR, two kinases in the PI3K/mTOR signaling pathway. By inhibiting these targets, the drug aims to disrupt signaling that supports cancer cell growth and survival. This mechanism is being evaluated in Phase 1 and Phase 2 clinical trials.
LY3023414 is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sole developer listed for this investigational agent.
LY3023414 is in Phase 1 clinical development, with additional Phase 2 evaluation in metastatic prostate cancer. It is investigational and has not been approved by the FDA for any indication. All listed trials are completed.
Completed trials include NCT02818335, a Phase 1 study of formulations and food effect in 30 healthy participants; NCT02575703, a Phase 1 study of [¹⁴C]-LY3023414 in 8 healthy participants; NCT02536586, a Phase 1 study in 12 Japanese participants with advanced cancer; and NCT02407054, a Phase 2 study of enzalutamide and LY3023414 in 142 men with metastatic prostate cancer.
Yes, LY3023414 Reference Fasted, LY3023414 Test Fed, and [¹⁴C]-LY3023414 are alternative names or formulations of the same investigational drug. The reference fasted and test fed labels refer to dosing conditions in a food effect study, while [¹⁴C]-LY3023414 is a radiolabeled version used in a mass balance study.