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IDH Inhibitor
LY3410738 for Solid Tumors
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
Cholangiocarcinoma patients with IDH1 R132, IDH2 R140, or IDH2 R172 mutations
Ability to swallow capsules or tablets.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new drug for patients with advanced solid tumors that have a specific mutation. The drug will be given orally to see if it is safe and effective.
Who is the study for?
Adults with advanced solid tumors that have specific mutations (IDH1 R132, IDH2 R140, or IDH2 R172) and are not responding to standard treatments. They should be in good physical condition (ECOG 0-1), able to swallow pills, and willing to use birth control. People who've had certain prior treatments or have active infections, uncontrolled diseases, brain metastases requiring steroids, or a history of severe immune-related side effects from other drugs can't join.Check my eligibility
What is being tested?
The trial is testing LY3410738—an oral drug—on its own for safety and early signs of effectiveness against tumors with particular genetic changes. It's an open-label study where everyone knows what treatment they're getting. The trial includes patients with cancers like cholangiocarcinoma and glioma after some previous treatments failed.See study design
What are the potential side effects?
Possible side effects aren't listed here but based on the nature of clinical trials for cancer drugs like LY3410738 which targets specific enzymes mutated in cancer cells; fatigue, nausea, liver issues, diarrhea or constipation could occur among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cholangiocarcinoma has specific IDH1 or IDH2 mutations.
Select...
I can swallow pills.
Select...
I have or had serious lung inflammation that needed strong medication.
Select...
My cancer has a specific genetic mutation (IDH1 or IDH2) confirmed by a certified lab.
Select...
I have been treated with anti-PD 1 or anti-PD L1 therapies before.
Select...
I am fully active or can carry out light work.
Select...
My cholangiocarcinoma has been confirmed and I've had 1-2 treatments, but no IDH1 inhibitors.
Select...
My bile duct cancer cannot be removed by surgery.
Select...
My bile duct cancer is advanced or has spread, and I've had at least one treatment.
Select...
I have had severe side effects from immune therapy.
Select...
I have an autoimmune disease treated with medication in the last 2 years.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Assess the safety and tolerability of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine or in combination with durvalumab
Characterize PK properties of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine or in combination with durvalumab
Objective Response Rate
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: LY3410738 alone or in combination with gemcitabine and cisplatin or in combination with durvalumabExperimental Treatment4 Interventions
Phase 1 dose expansion - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of LY3410738 alone or in combination with gemcitabine plus cisplatin or in combination with durvalumab
Group II: LY3410738Experimental Treatment1 Intervention
Phase 1 dose escalation - Multiple doses of LY3410738
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Durvalumab
2017
Completed Phase 2
~3870
Gemcitabine
2017
Completed Phase 3
~2070
LY3410738
2021
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,729 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
9,669 Total Patients Enrolled
Thomas XuStudy DirectorMedical Monitor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cholangiocarcinoma has specific IDH1 or IDH2 mutations.I can swallow pills.You need to have a tissue sample from a previous biopsy available for the study. If you don't have one, you should talk to the study sponsor's Medical Monitor before enrolling.I have previously been treated with an IDH1 inhibitor.My advanced cancer has not responded to standard treatments.I haven't taken any cancer drugs or investigational treatments in the last 2 to 4 weeks.I agree to use effective birth control during and for 3 months after treatment.I have cholangiocarcinoma and have not undergone specific liver treatments in the last 4 weeks, nor do I have complications like ascites, encephalopathy, ongoing cholangitis, mixed cancer types, or a liver transplant history.I have not had major surgery in the last 4 weeks.I have or had serious lung inflammation that needed strong medication.I have another type of cancer but it's in remission and I'm expected to live more than 2 years.You are allergic to LY3410738 or any of its ingredients.I haven't had systemic therapy for my advanced or metastatic disease.My bile ducts are properly drained and I have no current infections.My cancer is advanced, and standard treatments are not suitable for me.My cancer has a specific genetic mutation (IDH1 or IDH2) confirmed by a certified lab.My organs are working well.I have been treated with anti-PD 1 or anti-PD L1 therapies before.I haven't taken strong immune system suppressing drugs in the last 28 days, except for low-dose steroids or inhalers.I don't have active brain metastases and am not on steroids for them.I have a brain tumor without spread to the membranes, stable on steroids, and no brain bleeding.I don't have severe side effects from past treatments, except for hair loss.I have not had a heart attack or uncontrolled heart issues in the last 6 months.I do not have any active, uncontrolled infections or other serious health conditions.I have hepatitis B under control with treatment and a low viral load.I have hepatitis C but am either untreated, successfully treated, or have been clear of the virus for at least 4 weeks.I do not have HIV due to potential medication interactions.I am not on strong medications that affect liver enzymes or drug transporters.I do not have a condition that affects how my body absorbs medication.I am fully active or can carry out light work.My cholangiocarcinoma has been confirmed and I've had 1-2 treatments, but no IDH1 inhibitors.My bile duct cancer cannot be removed by surgery.I finished chemotherapy over 6 months ago before my cancer advanced.I am on my first or second round of cisplatin and gemcitabine, waiting for genetic test results, without disease progression.My bile duct cancer is advanced or has spread, and I've had at least one treatment.I have had severe side effects from immune therapy.I have an autoimmune disease treated with medication in the last 2 years.I am on hormone replacement therapy, which is allowed.I had targeted radiotherapy for symptom relief within the last week, except for brain treatment which was 4 weeks ago.I am 18 years old or older.You are able to regularly attend appointments, get blood work done, and follow treatment instructions.I have not received a live vaccine in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: LY3410738 alone or in combination with gemcitabine and cisplatin or in combination with durvalumab
- Group 2: LY3410738
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.
Are there numerous locations in the United States conducting this research?
"Massachusetts General Hospital in Boston, Mayo Clinic-Jacksonville in Jacksonville, and Mayo Clinic of Scottsdale in Phoenix are 3 trial sites for this study. In addition to these locations, there are 20 other enrolment centres around the country."
Answered by AI
Has the Food and Drug Administration bestowed its seal of approval upon LY3410738?
"Given the relatively scant amount of evidence attesting to LY3410738's safety and efficacy, its score on our risk assessment scale is a 1."
Answered by AI
How many test subjects are participating in this investigation?
"Correct. According to clinicaltrials.gov, the medical trial is actively seeking participants; it was first posted on October 16th 2020 and recently updated on November 18th 2022. A total of 200 patients are required from 20 different sites for enrollment in this research project."
Answered by AI
Is this investigation still open to further participants?
"According to clinicaltrials.gov, this investigation is actively recruiting participants since its initial posting on October 16th 2020 and most recent alteration on November 18th 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
UCSF Medical Center at Mission Bay
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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