A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors



Status:Active, not recruiting
Conditions:Breast Cancer, Colorectal Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:November 4, 2016
End Date:July 31, 2019

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A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as LY3039478
in combination with other anticancer agents in participants with advanced or metastatic solid
tumors.


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 for all combinations: The participant must have histological
or cytological evidence of cancer, either a solid tumor or a lymphoma, which is
advanced or metastatic.

- For Part A dose confirmation: All participants must have histological evidence of
advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer
participants must have prescreened mutations, amplification, or gene/protein
expression alterations related to Notch pathway.

- For Part B dose confirmation: All participants must have histological evidence of
advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer
participants must have prescreened mutations, amplification, or gene/protein
expression alterations related to Notch pathway.

- For Part C dose confirmation: All participants must have histological evidence of
advanced or metastatic breast cancer and prescreened mutations, amplification, or
gene/protein expression alterations related to Notch pathway.

- For Part D dose confirmation: All participants must have histological evidence of
cholangiocarcinoma and prescreened mutations, amplification, or gene/protein
expression alterations related to Notch pathway. Participants must not have
received >1 line of prior systemic therapy for metastatic or resectable disease
(that is, participants may have received adjuvant gemcitabine and then later
gemcitabine/cisplatin for recurrent metastatic disease).

- For Part E dose confirmation: All participants must have histological evidence of
locally advanced or metastatic triple negative breast cancer (TNBC) and
prescreened mutations, amplification, or gene/protein expression alterations
related to Notch pathway. Participants must not have received >2 lines of
systemic treatment for advanced or metastatic TNBC.

- Have adequate organ function.

- Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG)
scale.

- Have discontinued all previous therapies for cancer.

Exclusion Criteria:

- Have current acute leukemia.

- Have current or recent (within 3 months of study drug administration) gastrointestinal
disease with chronic or intermittent diarrhea, or disorders that increase the risk of
diarrhea, such as inflammatory bowel disease.
We found this trial at
5
sites
Copenhagen, København Ø
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Copenhagen,
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Detroit, Michigan 48201
Principal Investigator: Amy Weise
Phone: 313-576-8411
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from
Detroit, MI
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Shubham Pant
Phone: 713-563-5844
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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Miami, Florida 33136
Principal Investigator: Jaime Merchan
Phone: 305-243-1287
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from
Miami, FL
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: William Tap
Phone: 646-888-4163
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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mi
from
New York, NY
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