← Back to Search

LY3200882 for Solid 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

Participant must have histological or cytological evidence of cancer

Must have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to disease progression or death (estimated at up to 12 months)

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe for people with solid tumors.

Who is the study for?

This trial is for people with solid tumors who can prove their cancer diagnosis, have good organ function, and are in decent physical shape (ECOG status of 0 or 1). They must be able to take pills. It's not for those with serious heart disease, other severe illnesses, or acute leukemia.Check my eligibility

What is being tested?

The study is testing the safety of a new drug called LY3200882 on solid tumors. Participants will also receive established cancer treatments like nab-Paclitaxel, radiotherapy, Cisplatin, LY3300054, and Gemcitabine.See study design

What are the potential side effects?

Possible side effects may include reactions at the infusion site from drugs like nab-Paclitaxel and Cisplatin; skin irritation from radiotherapy; and general effects such as fatigue or digestive issues from all treatments.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer diagnosis was confirmed through lab tests on tissue or fluid samples.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to date of death from any cause (estimated at up to 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to date of death from any cause (estimated at up to 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death from any cause (estimated at up to 12 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

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)

Secondary outcome measures

Duration of Response (DoR)

ORR: Percentage of Participants with CR or PR

Overall Survival (OS)

+3 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: LY3200882 Schedule 2 ExpansionExperimental Treatment1 Intervention

Group II: LY3200882 Schedule 2 EscalationExperimental Treatment1 Intervention

Group III: LY3200882 Schedule 1 ExpansionExperimental Treatment1 Intervention

Group IV: LY3200882 Schedule 1 EscalationExperimental Treatment1 Intervention

Group V: LY3200882 + LY3300054Experimental Treatment2 Interventions

Group VI: LY3200882 + Gemcitabine + nab-PaclitaxelExperimental Treatment3 Interventions

Group VII: LY3200882 + Cisplatin + RadiationExperimental Treatment3 Interventions

Group VIII: Japanese Arm LY3200882Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity Modulated Radiotherapy

2016

N/A

~30

nab-Paclitaxel

2014

Completed Phase 3

~7680

Cisplatin

2013

Completed Phase 3

~1940

LY3200882

2019

Completed Phase 1

~30

LY3300054

2017

Completed Phase 1

~230

Gemcitabine

2017

Completed Phase 3

~2070

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,613 Previous Clinical Trials

3,200,706 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,344 Previous Clinical Trials

405,029 Total Patients Enrolled

Frequently Asked Questions

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

Does the drug LY3200882 pose any potential health risks?

"Limited clinical data exists to support LY3200882's safety and effectiveness, thus earning it a score of 1."

Answered by AI

To what medical conditions is LY3200882 typically prescribed?

"LY3200882 is widely prescribed for those who've received an anthracycline-containing chemotherapy regimen as adjuvant therapy. Additionally, this medication has demonstrated positive outcomes in patients with metastatic bladder cancer, neoplasm metastasis, and cases of locally advanced non-small cell lung cancer."

Answered by AI

What other investigations have been conducted in relation to LY3200882?

"LY3200882 was initially tested in 1997 at the City of Hope Comprehensive Cancer Center. Since then, a total 2494 studies have been completed and 1500 more are ongoing, with many taking place within Houston, Texas."

Answered by AI

How many people in total can take part in this clinical experiment?

"At this time, no more patients are being accepted into the study. It was initially posted on November 21st 2016 and saw its last update in September 19th 2022. For those seeking alternatives, there are currently 2585 studies enrolling patients with tumors or solid masses, as well as 1500 trials recruiting for LY3200882."

Answered by AI

Are new participants being accepted for this experiment at present?

"Data posted on clinicaltrials.gov indicates that this particular medical study is not presently recruiting new patients for participation. Initially published on November 21st 2016 and last updated September 19th 2022, the trial has temporarily halted recruitment efforts; however, there are 4085 other trials actively seeking participants at present."

Answered by AI

Are there numerous centers in the US that are conducting this research?

"Apart from the University of Texas MD Anderson Cancer Center in Houston, there are 3 other medical centres participating in this trial. These include the University of Louisville in Louisville and Weill Cornell Medical College located in New york City."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

First-in-human Phase I Study of a Next-generation, Oral, Tgfβ Receptor 1 Inhibitor, LY3200882, in Patients with Advanced Cancer

Yap, Timothy A., Maria Vieito, Capucine Baldini, Juan Manuel Sepúlveda-Sánchez, Shunsuke Kondo, Matteo Simonelli, Rasha Cosman, et al.. 2021. “First-in-human Phase I Study of a Next-generation, Oral, Tgfβ Receptor 1 Inhibitor, LY3200882, in Patients with Advanced Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-1504.

clinicaltrials.govStudy

A Study of LY3200882 in Participants With Solid Tumors

2016. "A Study of LY3200882 in Participants With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02937272.