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LY3410738 for Blood Cancers
Study Summary
This trial is testing a new drug for people with certain types of cancer who have already tried other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- 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
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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