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| ID | Type | Description | Link |
|---|---|---|---|
| I6A-MC-CBBA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have.
In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3023414 | Drug | Administered orally. Dose of 20 to 600 mg, as determined in Part A. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 dose | Baseline to disease progression or participant discontinuation (estimated 9 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum concentration (Cmax) | Predose up to 12 hours postdose | |
| Pharmacokinetics: Time of maximal concentration | Predose up to 12 hours postdose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| Memorial Sloan Kettering Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33660194 | Derived | Zauderer MG, Alley EW, Bendell J, Capelletto E, Bauer TM, Callies S, Szpurka AM, Kang S, Willard MD, Wacheck V, Varghese AM. Phase 1 cohort expansion study of LY3023414, a dual PI3K/mTOR inhibitor, in patients with advanced mesothelioma. Invest New Drugs. 2021 Aug;39(4):1081-1088. doi: 10.1007/s10637-021-01086-6. Epub 2021 Mar 4. |
| Label | URL |
|---|---|
| A Study of LY3023414 in Participants With Advanced Cancer | View source |
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| 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. |
|
| 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 |
|
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| Cisplatin | Drug | 75 mg/m2 administered IV once on Day 1 every 21 days |
|
| Abemaciclib | Drug | Administered orally |
|
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| Letrozole | Drug | Administered orally |
|
| Number of participants with tumor response |
| Baseline to disease progression or participant discontinuation (estimated 9 weeks) |
| Potential of LY3023414 to inhibit CYP3A4-mediated metabolism | Baseline through Cycle 1 |
| New York |
| New York |
| 10065 |
| United States |
| Peggy and Charles Stephenson Oklahoma Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
| Azienda Ospedaliero - Universitaria S. Luigi Gonzaga | Orbassano | Torino | 10043 | Italy |
| Fundacion de Investigacion de Diego | San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008228 | Lymphoma, Non-Hodgkin |
| D001943 | Breast Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008654 | Mesothelioma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C000621566 | LY3023414 |
| D008874 | Midazolam |
| D000077267 | Fulvestrant |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| C000590451 | abemaciclib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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