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A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

Phase 1
18 Years
Open (Enrolling)
Neoplasms, Neoplasm Metastasis, Lymphoma

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Trial Information

A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

In Part A of this study, participants with advanced/metastatic cancer (including lymphoma)
will receive increasing doses of LY3039478 to define the dose level for Part B. In Part B,
LY3039478 will be explored at a predefined fixed dose level. Participants in Part B must
have a defined alteration in a certain molecular pathway. Enrollment of participants in Part
B will start once Part A is completed.

Inclusion Criteria:

- For all parts: The participant must be, in the judgment of the investigator, an
appropriate candidate for experimental therapy after available standard therapies
have failed to provide clinical benefit for their advanced or metastatic cancer.

- For Dose Escalation (Part A): The participant must have histological or cytological
evidence of cancer, either a solid tumor or a lymphoma, which is advanced or

- For Dose Confirmation (Part B): All participants must have a histological evidence
of their advanced or metastatic cancer and prescreened alterations in a defined
pathway such as mutations, amplification or gene expressions related to the defined

- As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the
Revised Response Criteria for Malignant Lymphoma or the Response Assessment in Neuro
Oncology (RANO) criteria for glioblastoma:

- For Dose Escalation (Part A): Have measurable or nonmeasurable disease.

- For Dose Confirmation (Parts B): Have measurable disease or reliable biomarker
measure (example prostate-specific antigen [PSA], cancer antigen 125 [CA125]).

- Have adequate organ function including:

- Hematologic: 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 per deciliter
(g/dL). Participants may receive erythrocyte transfusions to achieve this
hemoglobin level at the discretion of the investigator; however, initial study
drug treatment must not begin earlier than the day after the erythrocyte

- Hepatic: Bilirubin no more than 1.5 times upper limits of normal (ULN) and
alanine aminotransferase (ALT) no more than 2.5 times ULN. If the liver has
tumor involvement, aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) equaling 5 times ULN are acceptable.

- Renal: calculated creatinine clearance at least 45 milliliters per minute

- Have a performance status of less than or equal to 1 on the Eastern Cooperative
Oncology Group (ECOG) scale and life expectancy of more than 12 weeks.

- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for
myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving
study drug, and recovered from the acute effects of therapy (treatment-related
toxicity resolved to baseline) except for residual alopecia. At the discretion of
the investigator, participants with breast or prostate cancers progressing on
therapies may have that treatment continued while receiving study drug.

Exclusion Criteria:

- Have received treatment with a drug that has not received regulatory approval for any
indication within 14 or 21 days of the initial dose of study drug for a
nonmyelosuppressive or myelosuppressive agent, respectively.

- Have serious preexisting medical conditions that, in the judgment of the
investigator, would preclude participation in this study (for example, inflammatory
bowel disease or history of major surgical resection involving the stomach or small

- Have central nervous system (CNS) malignancy, except:

- 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).

- Participants with glioblastoma are eligible.

- Have an acute leukemia.

- Have received an autologous or allogeneic stem-cell transplant.

- Females who are pregnant or lactating.

- Have active bacterial, fungal, and/or known viral infection (for example, human
immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or
hepatitis C antibodies). Screening is not required for enrollment.

- Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or
diarrhea (acute or chronic).

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants with Dose Limiting Toxicities (DLTs)

Outcome Time Frame:

Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks)

Safety Issue:


Principal Investigator

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


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

October 2012

Completion Date:

February 2016

Related Keywords:

  • Neoplasms
  • Neoplasm Metastasis
  • Lymphoma
  • Neoplasms
  • Lymphoma
  • Neoplasm Metastasis



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.Kalamazoo, Michigan  49048