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IDH Inhibitor
LY3410738 for Blood Cancers
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) 0 to 2
Patients must have a qualifying IDH1 R132, IDH2 R140 or IDH2 R172 mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
Study Summary
This trial is testing a new drug for people with certain types of cancer who have already tried other treatments.
Who is the study for?
This trial is for adults with advanced blood cancers (like AML) that have specific IDH1 or IDH2 mutations. Participants must be able to take oral medication, follow birth control measures if of reproductive potential, and have an ECOG score of 0-2 indicating they are relatively active. They can't join if they've had certain recent treatments, other active cancers, major surgery, uncontrolled infections, significant heart issues, or been on strong CYP3A4 inhibitors.Check my eligibility
What is being tested?
The study tests LY3410738—an oral drug targeting mutated enzymes in blood cancer cells—alone or with standard therapies like Venetoclax and Azacitidine. It's a Phase 1 trial where everyone gets the experimental treatment but at different doses to find the safest and most effective amount.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally may include gastrointestinal symptoms (nausea/vomiting), liver enzyme changes, fatigue, risk of infection due to bone marrow suppression by drugs like Venetoclax and Azacitidine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer has a specific IDH1 or IDH2 mutation.
Select...
I am 75 or older or cannot undergo intense chemotherapy due to other health issues.
Select...
I have relapsed or refractory AML and am in the US.
Select...
My blood cancer has an IDH mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the activity of LY3410738 as measured by the overall response rate (ORR) per the Investigator assessment
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
Secondary outcome measures
To assess the activity of LY3410738 as measured by Best Overall Response (BOR) per Investigator assessment
To assess the activity of LY3410738 as measured by the overall response rate (ORR) per Investigator assessment
To assess the activity of LY3410738 by Complete Remission (CR) Rate (CRR) plus partial hematologic recovery (AML patients)
+7 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Dose Escalation Arm C (LY3410738, Venetoclax, and Azacitidine)Experimental Treatment3 Interventions
Patients with no prior venetoclax therapy and not requiring a strong CYP3A4 inhibitor for active treatment within 7 days of starting LY3410738.
Group II: Dose Escalation Arm B (Monotherapy)Experimental Treatment1 Intervention
Patients requiring a strong CYP3A4 inhibitor for active management or prevention of a lifethreatening condition, such as an azole administered to prevent invasive fungal infection.
Group III: Dose Escalation Arm A (Monotherapy)Experimental Treatment1 Intervention
Patients not requiring a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
Group IV: Cohort 5Experimental Treatment3 Interventions
Patients with newly diagnosed AML, R/R AML, or other advanced hematologic malignancy harboring IDH1 and/or IDH2 mutations with no prior venetoclax therapy. Strong CYP3A4 inhibitor allowed but not required.
Group V: Cohort 4Experimental Treatment1 Intervention
Patients with R/R AML, MDS, CMML or other advanced hematologic malignancy harboring IDH2 mutations.
Group VI: Cohort 3Experimental Treatment1 Intervention
Patients with R/R MDS, chronic myelomonocytic leukemia (CMML) or other advanced hematologic malignancy harboring an IDH1 R132 mutation.
Group VII: Cohort 2Experimental Treatment1 Intervention
Patients with R/R AML harboring an IDH1 R132 mutation who have not received a prior IDH inhibitor.
Group VIII: Cohort 1Experimental Treatment1 Intervention
Patients with relapsed/refractory (R/R) AML harboring an IDH1 R132 mutation who have received a prior IDH inhibitor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
LY3410738
2021
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,798 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
9,609 Total Patients Enrolled
Elizabeth Olek, DO, MPHStudy DirectorLoxo Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been treated with venetoclax.I have not had major surgery in the last 4 weeks.I do not have HIV due to potential medication interactions.I do not have an ongoing serious infection or unexplained high fever.My cancer has a specific IDH1 or IDH2 mutation.I do not have a condition that affects how my body absorbs medication.I am not on strong medication that affects liver enzymes, except for some antifungals.I have not taken proton pump inhibitors in the last 7 days.I can take care of myself and am up and about more than half of my waking hours.I agree to use effective birth control during and for 3 months after treatment.I am not receiving treatment for another cancer.I have a serious heart condition.I haven't taken any cancer drugs or investigational treatments recently.I may have received up to 1 cycle of specific medication while waiting for my cancer's genetic test results.My cancer has spread to my brain or spinal cord.I am 75 or older or cannot undergo intense chemotherapy due to other health issues.My organs are working well.I can swallow pills.I have relapsed or refractory AML and am in the US.I don't have lasting side effects from previous treatments, except for hair loss.My blood cancer has an IDH mutation.I have active hepatitis B.I have not had a stem cell transplant or CAR-T therapy in the last 60 days.I have active hepatitis C.I am eligible for specific parts of the study.I have received treatment for my condition before.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Arm A (Monotherapy)
- Group 2: Dose Escalation Arm C (LY3410738, Venetoclax, and Azacitidine)
- Group 3: Cohort 1
- Group 4: Cohort 2
- Group 5: Cohort 5
- Group 6: Cohort 3
- Group 7: Dose Escalation Arm B (Monotherapy)
- Group 8: Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What primary aims is this experiment attempting to accomplish?
"This research endeavour, which will be tracked over a 30 month period, seeks to identify the maximum tolerated dose of LY3410738. Secondary objectives include monitoring safety and tolerability by tracking adverse events, assessing activity through complete response rate plus partial hematologic recovery (in AML patients), and gauging efficacy based on best overall response per investigator assessment."
Answered by AI
How many participants are engaging in this research?
"This medical experiment necessitates 260 volunteers with the requisite inclusion criteria. H Lee Moffitt Cancer Center in Tampa, Florida and Roswell Park Cancer Institute in Buffalo, New york are amongst the multiple sites from which participants may join this clinical trial."
Answered by AI
Are there multiple locations in North America running this research endeavor?
"The clinical study is being administered from H Lee Moffitt Cancer Center in Tampa, Florida; Roswell Park Cancer Institute in Buffalo, New york; and Princess Margaret Hospital in Toronto, Ontario as well as 14 other medical centres."
Answered by AI
Is enrollment still available for this research endeavor?
"Affirmative. According to the information located on clinicaltrials.gov, this research initiative is currently recruiting participants. It was first published in December 1st 2020 and has since been revised as of September 9th 2022; 260 enrollees are necessary from 14 different medical centers."
Answered by AI
Has the FDA granted authorization to LY3410738?
"There is limited evidence that LY3410738 has the capacity to be safe and efficacious, thus earning it a score of 1."
Answered by AI
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