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A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT02857270•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have advanced or metastatic cancer (solid tumors) and be an appropriate candidate for experimental therapy.
•* 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 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.
+4 more criteria

Locations (13)

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

Key Dates

Start Date

September 29, 2016

Primary Completion Date

February 10, 2021

Completion Date

October 24, 2022

Last Updated

November 22, 2022

Enrollment

210

ACTUAL participants

Conditions

Advanced CancerMetastatic MelanomaMetastatic Non-small Cell Lung CancerColorectal Cancer

Interventions

LY3214996

DRUG

Midazolam

DRUG

Abemaciclib

DRUG

Nab-paclitaxel

DRUG

Gemcitabine

DRUG

Encorafenib

DRUG

Cetuximab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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