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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer, Metastatic Cancer, Lymphoma, Metastatic Breast Cancer, Malignant Mesothelioma

Thank you

Trial Information

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


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%

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended Phase 2 dose

Outcome Time Frame:

Baseline to disease progression or participant discontinuation (estimated 9 weeks)

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13517

NCT ID:

NCT01655225

Start Date:

July 2012

Completion Date:

August 2014

Related Keywords:

  • Advanced Cancer
  • Metastatic Cancer
  • Lymphoma
  • Metastatic Breast Cancer
  • Malignant Mesothelioma
  • Advanced Breast Cancer
  • Breast Neoplasms
  • Lymphoma
  • Mesothelioma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

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.Manhassaet, New York  
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.Tulsa, Oklahoma  74136
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.Memphis, Tennessee  38138