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A Study of LY3023414 in Participants With Advanced Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of LY3023414 in Participants With Advanced Cancer

A Phase 1 First-in-Human Dose Study of LY3023414 in Patients With Advanced Cancer

NCT01655225•Eli Lilly and Company

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Parts A, A2 \& B1: Participants must have pathological evidence of a diagnosis of advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy
•Part B2: Participants must have advanced, recurrent, or metastatic breast cancer that is refractory to aromatase inhibitors (AI) with either disease recurrence or disease progression; must be hormone receptor positive (HR+) and human epidermal growth factor receptor 2 (HER2)-negative; must be of postmenopausal status or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist
•Part B3 only: Participants must have malignant pleural or peritoneal mesothelioma
•Part B4 only: Participants must have malignant pleural or peritoneal mesothelioma and appropriate candidate for treatment with cisplatin/pemetrexed; no prior systemic chemotherapy
•Part B5 only: Participants must have histologically confirmed diagnosis of B-cell iNHL, with histological subtype; prior treatment with ≥2 prior chemotherapy- or immunotherapy-based regimens for iNHL
•Part B6 only: Participants must have squamous NSCLC; documented evidence of an activating molecular aberration of the PI3K/mTOR pathway
•Parts B2, B3 \& B6 only: Must have adequate tumor tissue sample from archival biopsy available, or willingness to undergo a fresh tumor biopsy
•Parts B3, B4, B5 \& B6: No previous treatment with any PI3K and/or mTOR inhibitor
•Part B7: Must have a diagnosis of HR+ and HER2- breast cancer; have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease; no previous treatment or currently receiving 1 of the following treatments for locoregionally recurrent or metastatic breast cancer (chemotherapy, endocrine therapy, CDK4/6 inhibitor, and PI3K and/or mTOR inhibitor)
•Measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1), modified RECIST or Revised Response Criteria for Malignant Lymphoma
+4 more criteria

Exclusion Criteria

•Have serious preexisting medical conditions
•Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required).
•Have known acute or chronic leukemia or current hematologic malignancies (except iNHL for patients in Part B5) that, in the judgment of the investigator and sponsor, may affect the interpretation of results
•Have an active fungal, bacterial, and/or known viral infection
•Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results (Part B only)
•Part B1 only: No concomitant medications that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) or midazolam
•Intolerance to any previous treatment with any phosphatidylinositol-3-kinase (PI3K) and/or mammalian target of rapamycin (mTOR) inhibitor.
•Participants with active alcohol abuse, as determined by the investigator
•Have a history of New York Heart Association (NYHA) Class ≥3, unstable angina, or myocardial infarction (MI) in 6 months prior to study drug administration
•Have QT corrected interval of \>450 milliseconds (msec) on screening electrocardiogram (ECG)
+2 more criteria

Locations (8)

UCLA Medical Center

Los Angeles, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Peggy and Charles Stephenson Oklahoma Cancer Center

Oklahoma City, Oklahoma, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

Azienda Ospedaliero - Universitaria S. Luigi Gonzaga

Orbassano, Torino, Italy

Fundacion de Investigacion de Diego

San Juan, Puerto Rico

Key Dates

Start Date

July 31, 2012

Primary Completion Date

April 4, 2019

Completion Date

February 2, 2022

Last Updated

April 8, 2022

Enrollment

156

ACTUAL participants

Conditions

Advanced CancerMetastatic CancerNon-Hodgkin's LymphomaMetastatic Breast CancerMalignant MesotheliomaNon-small Cell Lung Cancer

Interventions

LY3023414

DRUG

Midazolam

DRUG

Fulvestrant

DRUG

Pemetrexed

DRUG

Cisplatin

DRUG

Abemaciclib

DRUG

Letrozole

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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RECRUITINGPHASE1

Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer

NCT07197671

Metastatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY3023414 in Participants With Advanced Cancer

Inclusion Criteria

Exclusion Criteria

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