LY3410738 for Glioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioma+3 More
LY3410738 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Glioma
  • Any Solid Tumor
  • Cholangiocarcinoma
  • Chondrosarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Glioma

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to 24 months

Up to 24 months
Assess the safety and tolerability of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine or in combination with durvalumab
Assess the safety and tolerability of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine.
Characterize PK properties 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.
Objective Response Rate
Recommended Phase 2 Dose (RP2D)
Recommended Phase 2 dose (RP2D)
To assess the preliminary anti-tumor activity of LY3410738 monotherapy and in combination with cisplatin plus gemcitabine
To assess the preliminary anti-tumor activity of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine or in combination with durvalumab
To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma
To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma.

Trial Safety

Safety Progress

1 of 3

Other trials for Glioma

Trial Design

2 Treatment Groups

LY3410738 alone or in combination with gemcitabine and cisplatin or in combinati...
1 of 2
LY3410738
1 of 2
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: LY3410738 · No Placebo Group · Phase 1

LY3410738 alone or in combination with gemcitabine and cisplatin or in combination with durvalumabExperimental Group · 4 Interventions: Durvalumab, Gemcitabine, Cisplatin, LY3410738 · Intervention Types: Drug, Drug, Drug, Drug
LY3410738
Drug
Experimental Group · 1 Intervention: LY3410738 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3200
Gemcitabine
2017
Completed Phase 3
~2940
Cisplatin
2013
Completed Phase 3
~2700

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Loxo Oncology, Inc.Industry Sponsor
39 Previous Clinical Trials
7,299 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,451 Previous Clinical Trials
3,120,484 Total Patients Enrolled
7 Trials studying Glioma
450 Patients Enrolled for Glioma
Thomas XuStudy DirectorMedical Monitor
Nikhil ShuklaStudy DirectorMedical Monitor
Kamnesh PradhanStudy DirectorMedical Monitor

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to use effective birth control for the duration of treatment and for 3 months following the last dose of study treatment.
A locally advanced or metastatic solid tumor, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator.
You are at least 18 years of age.
You have a normal or near-normal organ function.
You are able to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.