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Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments using LY3023414, Midazolam and Letrozole for patients

Research Study Title

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

Purpose

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, including but not limited to lymphoma, breast cancer, and mesothelioma. 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 cancer and mesothelioma.

To Learn more
Phase

1

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Eli Lilly and Company

Duration

26 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Participants must have histological or cytological evidence of a diagnosis of cancer (solid tumor or lymphoma) that is advanced and/or metastatic and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed or for whom standard therapy would not be appropriate

  • Measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) 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

Exclusion Criteria:

  • Have serious preexisting medical conditions

  • Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days (screening not required)

  • Have known acute or chronic leukemia or current hematologic malignancies 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, including: human immunodeficiency virus (HIV), or hepatitis A, B or C. Hepatocellular cancer (HCC) participants with chronic viral (B or C) hepatitis are eligible if they retain adequate liver function per Child-Pugh Stage A

  • 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. Treatment with any PI3K and/or mTOR inhibitor must have discontinued at least 5 half-lives prior to study enrollment and participants must have recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline or less than Grade 1). In Part B, no previous treatment with any PI3K and/or mTOR inhibitor is allowed

  • 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 interval corrected using Fridericia's formula (QTcF) of > 450 milliseconds (msec) on screening electrocardiogram (ECG)

  • Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c < 7%

Site Locations (3)

Country State City Zip Facility and Contact
United States New York New York 10065 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly
United States Oklahoma Oklahoma City 73104 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly
United States Tennessee Nashville 37203 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly

Contact

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559

NCT ID: NCT01655225

Date Last Changed: June 6, 2014

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