CompletedPhase 1NCT02857270
Official study titleA Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
Study 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.
Ask AI to explain this studyStart here
Key things to know
Main goalTreatment
This describes the study’s primary purpose.
What is being studiedLY3214996 and Midazolam
Plus 5 other study approaches.
Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 22, 2022 · Source: ClinicalTrials.gov
Is enrollment open?Completed
Ask the study team to confirm whether enrollment is open.
What kind of study?Phase 1
Interventional
Where is it offered?13 U.S. locations
Locations may change over time.
Who runs it?Eli Lilly and Company
Study sponsor
Study overview
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: LY3214996; Drug: Midazolam; Drug: Abemaciclib; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Encorafenib; Drug: Cetuximab
Explore related studies
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Cancer type
Disease setting
Treatment approach
Public criteria
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Requirements people may need to meetInclusion 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 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.
Reasons someone may not be able to joinExclusion 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
Study sites
U.S. locations
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Florida Cancer SpecialistsSarasota, Florida
- Massachusetts General HospitalBoston, Massachusetts
- Dartmouth Hitchcock Medical CenterLebanon, New Hampshire
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
- Sarah Cannon Cancer CenterNashville, Tennessee
- Tennessee Oncology PLLCNashville, Tennessee
- University of Texas MD Anderson Cancer CenterHouston, Texas
- St Vincent's HospitalSydney, New South Wales
- Linear Clinical Research LtdNedlands, Western Australia
- Gustave RoussyVillejuif
- Shizuoka Cancer CenterSunto-Gun, Shizuoka
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 22, 2022. Always confirm current availability with the study team.