A Study of LY3023414 in Participants With Advanced Cancer



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 31, 2012
End Date:March 13, 2020
Contact:There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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

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.


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

- Have adequate organ function, including: Absolute neutrophil count (ANC) at least 1.5
x 109/Liter (L), platelets at least 100 x 109/L, and hemoglobin at least 8
grams/deciliter (g/dL); bilirubin no more than 1.5 times upper limits of normal;
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no more than 2.0
times upper limits of normal; Serum creatinine no more than 1.5 times upper limits of
normal or calculated creatinine clearance >45 milliliters/minute (mL/min)

- Have a performance status of at least 1 on the Eastern Cooperative Oncology Group
(ECOG) scale and life expectancy >6 months

- Have discontinued all previous cancer therapies (except nonsteroidal aromatase
inhibitors for participants in Part B2), and any agents that have not received
regulatory approval for any indication, for at least 21 days or 5 half lives prior to
study enrollment, whichever is shorter, and recovered from the acute effects of
therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at
least 42 days

- Are able to swallow capsules

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)

- Have insulin-dependent diabetes mellitus or a history of gestational diabetes
mellitus.

- Part B only: Hypersensitivity to study drugs given in combination with LY3023414
We found this trial at
7
sites
Philadelphia, Pennsylvania
Principal Investigator: Evan W Alley
Phone: 800-789-7366
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Parvin Fatheddin Peddi
Phone: 3103258252
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Chock Bendell
Phone: 6153297274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-239-7615
Sarah Cannon Cancer Center People who live with cancer
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Anna M Varghese
Phone: 646-888-4226
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Oklahoma City, Oklahoma 73104
Principal Investigator: Raid Maki Dawood Aljumaily
Phone: 405-271-8777
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Orbassano,
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