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LY3214996 in Patients With AML Who Are Not Candidates for Standard Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE1

LY3214996 in Patients With AML Who Are Not Candidates for Standard Therapy

A Phase 1 Study of LY3214996, an ERK1/2 Inhibitor, in Patients With AML Who Are Not Candidates for Standard Therapy

NCT04081259•Dana-Farber Cancer Institute

Summary

This research study is evaluating a targeted therapy as a possible treatment for acute myeloid leukemia (AML) that has returned or not responded to standard treatment.

Detailed Description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved LY3214996 as a treatment for any disease. LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor that is being developed as a treatment for patients with advanced cancer. ERK inhibitors stop the signal that a cancer cell receives telling it to grow. In this research study, the investigators are testing to see if LY3214996 is a safe treatment for AML that has returned or not responded to standard treatment. Several doses of the study drug will be explored in this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically confirmed acute myeloid leukemia (AML) diagnosed per WHO criteria.
•Participants must have relapsed or refractory AML.
•Age ≥ 18 years.
•ECOG performance status ≤ 2
•Participants must have adequate organ function as defined below:
•* Direct Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
•* AST (SGOT) and ALT(SGPT) ≤ 2.5 × institutional ULN, OR
•* AST (SGOT) and ALT (SGPT) ≤ 5 × institutional ULN if elevation is a result of leukemia
•* Creatinine Clearance ≥ 60 mL/min/1.73 m2 (calculated via the Cockcroft-Gault equation)
•The effects of LY3214996 on the developing human fetus are unknown. For this reason and because anti-cancer agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of LY3214996 administration.
+9 more criteria

Exclusion Criteria

•Participants who have had chemotherapy, other investigational therapy, immunotherapy, or radiotherapy within 2 weeks prior to the first dose of study medication. ATRA treatment is permitted with no required washout if treatment duration was for less than 1 week. Hydroxyurea is allowed with no required washout. For participants with an absolute peripheral blast count \> 20 K/µL, hydroxyurea may be administered up to day 14 of protocol therapy with a maximum allowed dose of 6 g per day.
•Participants who have received oral tyrosine kinase inhibitors (TKIs) within 5 half-lives of the first dose of study medication.
•Participants who have had major surgery within 4 weeks prior to the first dose of study medication.
•Participants who have had a prior stem cell transplant (SCT) within 90 days prior to the first dose of study medication. Additionally, participants having undergone prior SCT must be off calcineurin inhibitor therapy for at least 28 days prior to the first dose of study medication.
•Participants with active \> Grade 1 acute or chronic Graft v. Host Disease (GvHD) who are receiving immunosuppressive therapy other than prednisone. Use of prednisone is permitted only if participants have been maintained at a steady dose of \< 20 mg/day for at least 5 days prior to the first dose of study medication.
•Participants with known active CNS leukemia involvement. Participants with no known history of CNS leukemia are not required to undergo lumbar puncture (LP) for trial eligibility unless the participant is symptomatic as judged by the treating investigator. Participants with a history of CNS leukemia involvement are eligible provided that the CNS disease has been adequately treated and cleared prior to study enrollment as judged by the treating investigator.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to LY3214996.
•Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Pregnant women are excluded from this study because LY3214996 is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LY3214996, breastfeeding should be discontinued if the mother is treated with LY3214996. A negative serum pregnancy test is required for women of childbearing potential prior to study entry.
•Participants who are known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B or C. Testing is not required for eligibility.
+1 more criteria

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

July 15, 2020

Primary Completion Date

August 3, 2023

Completion Date

August 26, 2023

Last Updated

May 8, 2025

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

LY3214996

DRUG

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITINGPHASE2

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

NCT06220162

Acute Myeloid Leukemia

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RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399

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: May 8, 2025Data 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.

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LY3214996 in Patients With AML Who Are Not Candidates for Standard Therapy

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2