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Also known as LY3023414 Test Fed, [¹⁴C]-LY3023414
LY3023414 · 3 trials · 8 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 | 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 |
| 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 the treatment of advanced cancer, neoplasm, and metastatic prostate cancer. It is a Phase 1 agent in the oncology therapeutic area and has been studied in controlled clinical trials, including biomarker-selected patient populations.
LY3023414 targets PI3K and mTOR, two components of a signaling pathway frequently altered in cancer. By inhibiting PI3K/mTOR, the drug is designed to interfere with signaling that supports tumor cell growth and survival. This mechanism underlies its investigation across advanced solid tumors and metastatic prostate cancer.
LY3023414 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly has sponsored the clinical program for the compound, including studies conducted in the United States, Italy, Puerto Rico, and Japan.
LY3023414 is in Phase 1 clinical development and is investigational. It has not been established as approved for any indication. The program includes completed Phase 1 and Phase 2 studies, with no active trials currently listed, and a total of 156 participants enrolled across the reported studies.
LY3023414 has been evaluated in completed trials including NCT01655225, a Phase 1 study in advanced cancer with 156 participants; NCT02407054, a Phase 2 study of enzalutamide plus LY3023414 in metastatic prostate cancer with 142 men; and NCT02536586, a Phase 1 study in Japanese participants with neoplasm.
LY3023414 is also referred to as LY3023414 Reference Fasted, LY3023414 Test Fed, and [¹⁴C]-LY3023414. These names describe the same compound studied under different dosing or labeling conditions, including a radiolabeled carbon-14 version used in clinical pharmacology assessments.