A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
NCT ID: NCT02857270
Last Updated: 2022-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
210 participants
INTERVENTIONAL
2016-09-29
2022-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LY3214996 Dose Escalation
LY3214996 given orally once a day (or twice a day) for 21 days.
LY3214996
Administered orally
LY3214996 + Midazolam
(Preliminary Drug-Drug Interactions \[DDI\])
LY3214996 given orally (once a day) and midazolam given orally on cycle 1 day 1 and cycle 1 day 16 (21 day cycles except cycle 1 only = 22 days).
LY3214996
Administered orally
Midazolam
Administered orally
LY3214996 Dose Expansion
LY3214996 given orally (once a day) during each 21 day cycle.
LY3214996
Administered orally
LY3214996 + Abemaciclib
Dose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and abemaciclib given orally (single dose given during lead in period) twice a day every 12 hours during 21 day cycle.
LY3214996
Administered orally
Abemaciclib
Administered orally
LY3214996 + Nab-Paclitaxel + Gemcitabine
Dose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and nab-paclitaxel given intravenously (IV) on day 1, 8, and 15 and gemcitabine IV on day 1, 8, and 15 during each 28 day cycle.
LY3214996
Administered orally
Nab-paclitaxel
Administered IV
Gemcitabine
Administered IV
LY3214996 + Encorafenib + Cetuximab
Dose Escalation and Expansion- LY3214996 given orally, encorafenib given orally and cetuximab given IV.
LY3214996
Administered orally
Encorafenib
Administered orally
Cetuximab
Administered IV
Japan Part 1
LY3214996 given orally.
LY3214996
Administered orally
Japan Part 2
LY3214996 given orally and abemaciclib given orally.
LY3214996
Administered orally
Abemaciclib
Administered orally
Interventions
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LY3214996
Administered orally
Midazolam
Administered orally
Abemaciclib
Administered orally
Nab-paclitaxel
Administered IV
Gemcitabine
Administered IV
Encorafenib
Administered orally
Cetuximab
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part B (No Longer Enrolling Participants): 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 a NRAS mutation, or 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, or NRAS mutant melanoma (dose expansion).
* Part D (No Longer Enrolling Participants): Have metastatic pancreatic ductal adenocarcinoma (dose escalation and dose expansion).
* Part E: Metastatic BRAF V600E colorectal cancer.
* Have adequate organ function.
* Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Exclusion Criteria
* 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.
* Part C: have serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study, including interstitial lung disease (ILD) or severe dyspnea at rest or requiring oxygen therapy.
* Part C4 NRAS Melanoma: have previously completed or withdrawn from a study investigating a MEK inhibitor.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
St Vincent's Hospital
Sydney, New South Wales, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Gustave Roussy
Villejuif, , France
Shizuoka Cancer Center
Sunto-Gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Countries
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References
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Bhagwat SV, McMillen WT, Cai S, Zhao B, Whitesell M, Shen W, Kindler L, Flack RS, Wu W, Anderson B, Zhai Y, Yuan XJ, Pogue M, Van Horn RD, Rao X, McCann D, Dropsey AJ, Manro J, Walgren J, Yuen E, Rodriguez MJ, Plowman GD, Tiu RV, Joseph S, Peng SB. ERK Inhibitor LY3214996 Targets ERK Pathway-Driven Cancers: A Therapeutic Approach Toward Precision Medicine. Mol Cancer Ther. 2020 Feb;19(2):325-336. doi: 10.1158/1535-7163.MCT-19-0183. Epub 2019 Nov 19.
Related Links
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A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
Other Identifiers
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I8S-MC-JUAB
Identifier Type: OTHER
Identifier Source: secondary_id
2016-001907-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16419
Identifier Type: -
Identifier Source: org_study_id
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