A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer



Status:Recruiting
Conditions:Lung Cancer, Colorectal Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:September 29, 2016
End Date:December 15, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer

The purpose of this study is to determine the safety of an extracellular signal regulated
kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in
participants with advanced cancer.


Inclusion Criteria:

- Have advanced or metastatic cancer (solid tumors) and be an appropriate candidate for
experimental therapy.

- Part B: Have advanced or metastatic cancer with an activating mitogen-activated
protein kinase pathway alteration, BRAF mutant metastatic melanoma refractory to
or relapsed after treatment with RAF and/or MEK inhibitors, metastatic melanoma
with an NRAS mutation, BRAF mutant NSCLC.

- Part C: Advanced, unresectable cancer (dose escalation) and advanced,
unresectable, or metastatic non-small cell lung cancer with a BRAF or RAS
mutation, and colorectal cancer with a RAS mutation and advanced or metastatic
cancer with an activating mitogen activated protein kinase pathway alteration
(dose expansion).

- Part D: Have metastatic pancreatic ductal adenocarcinoma (dose escalation and
dose expansion).

- Have discontinued previous treatments for cancer and have resolution, except where
otherwise stated in the inclusion criteria, of all clinically significant toxic
effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤1 by National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.

- Have adequate organ function.

- Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG)
scale.

Exclusion Criteria:

- Have serious preexisting medical conditions.

- Have a known human immunodeficiency virus (HIV) infection or known
activated/reactivated hepatitis A, B, or C.

- Have symptomatic central nervous system malignancy or metastasis.

- Have current hematologic malignancies, acute or chronic leukemia.

- Have a second primary malignancy that in the judgment of the investigator or Lilly may
affect the interpretation of results.

- Have prior malignancies. Participants with carcinoma in situ of any origin and
participants with prior malignancies who are in remission and whose likelihood of
recurrence is very low, as judged by the Lilly clinical research physician, are
eligible for this study.

- Have a mean QT interval corrected for heart rate (QTc) of ≥470 milliseconds on
screening electrocardiogram (ECG) as calculated using the Bazett's formula at several
consecutive days of assessment.

- Have participated, within the last 28 days in a clinical trial involving an
investigational product or are currently enrolled in a clinical trial involving an
investigational product or any other type of medical research judged not to be
scientifically or medically compatible with this study.

- Have previously completed or withdrawn from this study or any other study
investigating an ERK1/2 inhibitor.

- If female, is pregnant, breastfeeding, or planning to become pregnant.

- Have history or findings of central or branch retinal artery or venous occlusion with
significant vision loss or other retinal diseases that cause current visual impairment
or would likely cause visual impairment over the time period of the study.

- Currently using concomitant medications that are strong inhibitors or inducers of
CYP3A4.
We found this trial at
9
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Stephen V Liu
Phone: 202-444-2223
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington,
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ryan Sullivan
Phone: 617-643-3614
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Boston, MA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Shubham Pant
Phone: 713-745-6601
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Konstantin Dragnev
Phone: 603-650-6344
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
Sarah Cannon Cancer Center People who live with cancer
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Nashville, TN
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Chock Bendell
Phone: 6153297274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Timothy F Burns
Phone: 412-864-7859
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Pittsburgh, PA
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Sarasota, Florida 34232
Principal Investigator: Manish Rajni Patel
Phone: 9413779993
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Sarasota, FL
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Sydney, New South Wales
Principal Investigator: Anthony Joshua
Phone: 61293555655
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Sydney,
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