← Back to Search

Targeted Therapy

LY3214996 for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Richard Stone, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤ 2

Ability to swallow and retain oral medication.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a new therapy for people with AML who have relapsed or didn't respond to standard treatment.

Who is the study for?

Adults with acute myeloid leukemia (AML) that has returned or is unresponsive to standard treatments can join this trial. They must be able to sign consent, not have had a stem cell transplant recently, and agree to use contraception. Those on certain antifungal drugs affecting liver enzyme activity are included in specific arms of the study.Check my eligibility

What is being tested?

The trial is testing LY3214996, a targeted therapy for AML patients who haven't responded well to other treatments. It's designed to see if this drug can help where others haven't by blocking cancer growth signals.See study design

What are the potential side effects?

While the side effects of LY3214996 aren't fully known due to its experimental nature, similar cancer therapies often cause fatigue, nausea, liver issues, and increased risk of infection. Participants will be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I can swallow and keep down pills.

Select...

I am 18 years old or older.

Select...

My side effects from previous cancer treatments are mild or gone.

Select...

I have been diagnosed with acute myeloid leukemia according to WHO standards.

Select...

My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.

Select...

My AML cancer has returned or is not responding to treatment.

Select...

I am currently taking strong antifungal medication.

Select...

I am not taking strong antifungal medications like fluconazole or ketoconazole.

Select...

I am currently taking strong antifungal medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity

Secondary outcome measures

Overall Response Rate

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Dose Escalation LY3214996Experimental Treatment1 Intervention

-LY3214996 will be administered by mouth once daily continuously throughout each treatment cycle for patients with inhibitors for fungal prophylaxis/treatment

Group II: Arm A: Dose Expansion LY3214996Experimental Treatment1 Intervention

-LY3214996 will be administered by mouth once daily continuously throughout each treatment cycle for patients without inhibitors for fungal prophylaxis/treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3214996

2019

Completed Phase 2

~270

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,080 Previous Clinical Trials

340,895 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,624 Previous Clinical Trials

3,216,755 Total Patients Enrolled

Richard Stone, MDPrincipal Investigator - Dana-Farber Cancer Institute

Dana-Farber Cancer Institute

Harvard Medical Sch (Medical School)

Brigham & Women'S Hospital (Residency)

6 Previous Clinical Trials

339 Total Patients Enrolled

Media Library

LY3214996 (Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04081259 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Arm A: Dose Expansion LY3214996, Arm B: Dose Escalation LY3214996

LY3214996 (Targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04081259 — Phase 1

Acute Myeloid Leukemia Clinical Trial 2023: LY3214996 Highlights & Side Effects. Trial Name: NCT04081259 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What status has the FDA granted to LY3214996?

"Since LY3214996 is currently in the early stages of trial, with limited proof of safety and efficacy, Power ranked it a 1 on its rating scale."

Answered by AI

How many participants has this clinical trial enrolled thus far?

"Affirmative. The information housed on clinicaltrials.gov shows that this research venture, which was first published 15th July 2020, is presently recruiting volunteers. Approximately 30 individuals must be gathered from 1 location."

Answered by AI

Is this research endeavor still actively searching for participants?

"Yes, the data hosted on clinicaltrials.gov affirms that this medical trial is still open for recruitment. This study was initially posted in July 2020 and edited as recently as June 2022; 30 participants are needed from a single enrolment site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Rahul Vedula, MD 2020. "LY3214996 in Patients With AML Who Are Not Candidates for Standard Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04081259.