A Study of LY3039478 in Participants With Advanced Cancer



Status:Completed
Conditions:Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:October 2012
End Date:June 26, 2018

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

The purpose of this study is to find a recommended dose level of LY3039478 that can safely be
taken by participants with advanced cancer or cancer that has spread to other parts of the
body, including but not limited to lymphoma. The study will also explore changes to various
markers in blood cells and tissue. Finally, the study will help to document any tumor
activity this drug may have.

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, C, D and E.
In Part B, C, D and E LY3039478 will be explored at a predefined fixed dose level.
Participants in Part B and D must have a defined alteration in a certain molecular pathway.
Enrollment of participants in Part B, C, D and E will start once Part A is completed. In Part
F participants will receive increasing doses of LY3039478 in combination with prednisone to
define the maximum tolerated dose level.

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
metastatic.

- For Part B: All participants must have a histological evidence of their advanced or
metastatic cancer and prescreened alterations in a defined pathway.

- For Part C: All participants must have histological evidence of advanced or metastatic
specific subtypes of soft tissue sarcoma.

- For Part D: All participants must have histological evidence of advanced or metastatic
cancer and prescreened alterations in a defined pathway.

- Cohort 1: Participants must have triple negative breast cancer.

- Cohort 2: Participants must have hepatocellular carcinoma (HCC). These participants
should have Child-Pugh stage A.

- Cohort 3: Participants must have cholangiocarcinoma.

- Cohort 4: Participants must have chronic lymphocytic leukemia.

- Cohort 5: Participants must have a mature T cell, B cell, or natural killer (NK) cell
neoplasm.

- For Part E: Participants must have adenoid cystic carcinoma (ACC).

- For Part F dose confirmation: Participants must have leiomyosarcoma and prescreened
alterations in a defined pathway.

- 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 Parts B, C, D, E and F: Have measurable disease or reliable biomarker
measure.

- For Parts B, C, D, E and F: Have available tumor tissue.

- Have adequate organ function.

- 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.

Exclusion Criteria:

- Have symptomatic or non stable central nervous system (CNS) malignancy.

- Females who are pregnant or lactating.

- Have active bacterial, fungal, and/or known viral infection.

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

- Participants with HCC that:

- Have known HCC with fibro-lamellar or mixed histology.

- Have presence of clinically relevant ascites.

- Have had a liver transplant.

- Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C
virus infection.
We found this trial at
6
sites
Miami, Florida 33136
Principal Investigator: Dr. J.R. Merchan
Phone: 305-243-1287
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Sanjay Goel
Phone: 718-405-8510
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: David Smith
Phone: 734-936-7469
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Boston, Massachusetts 02115
Principal Investigator: Jennifer Brown
Phone: 617-632-3000
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Kobenhavn,
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Nicole Lamanna
Phone: 646-317-5205
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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