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IDO1 Inhibitor

Epacadostat + Sirolimus for Advanced Cancers

Phase 1

Waitlist Available

Led By Chao Huang, MD

Research Sponsored by Chao Huang

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status #0-2

No prior ≥ Grade 3 immune-related adverse event (irAE) while receiving immunotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective. So far, it has only been tested on a small number of people.

Who is the study for?

Adults with advanced solid tumors, specifically those with non-small cell lung cancer (NSCLC) that has worsened after first-line treatment. Participants must be over 18, have adequate organ function, and not have any health issues or treatments that could affect the study's results. They should not be pregnant or nursing and must agree to use contraception.Check my eligibility

What is being tested?

The trial is testing Epacadostat in combination with Sirolimus on patients with advanced malignancies. It includes a dose escalation phase to determine safe dosage levels followed by a dose expansion phase to further assess safety for NSCLC patients who've had prior therapy.See study design

What are the potential side effects?

Potential side effects may include immune system reactions affecting various organs, infusion-related responses, fatigue, digestive disturbances, blood disorders, increased risk of infections and specific organ inflammation such as pneumonitis.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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I have never had a severe reaction to immunotherapy.

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I am not using, nor do I plan to use, drugs that affect CYP3A4 enzyme activity.

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I am not taking any UGT1A9 inhibitor medication.

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I have never had lung scarring or inflammation not caused by infections.

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I have not had any eye problems due to immune-related side effects.

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I have received at least one round of systemic therapy.

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I am 18 years old or older.

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I do not have active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Incidence of treatment-emergent adverse events.

Secondary outcome measures

Disease control rate (DCR) >40% in subjects with NSCLC (dose expansion cohort)

Median Overall Survival (mOS) > 6 months in subjects with NSCLC (dose expansion cohort)

Median progression free survival (mPFS) >3 months in subjects with NSCLC (dose expansion cohort)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sirolimus/Epacadostat Dose ExpansionExperimental Treatment2 Interventions

Once recommended phase 2 dose (RP2D) is defined, a total of 10 non-small cell lung cancer (NSCLC) patients who meet eligibility will be enrolled in the dose expansion cohort. Treatment will be sirolimus RP2D once daily and epacadostat RP2D twice daily (BID). Sirolimus lead-in phase: loading dose on day -7 and maintenance dose starting day -6. On Cycle 1 Day 1, epacadostat 300mg BID will be added.

Group II: Sirolimus/Epacadostat Dose EscalationExperimental Treatment2 Interventions

Traditional 3 + 3 dose escalation design. Starting doses: sirolimus 3milligrams (mg) loading/1mg maintenance and epacadostat 300mg twice daily (BID). If 0 in 3 subjects develops dose limiting toxicity (DLT), next 3 subjects will be treated at dose level 2 (DL2): sirolimus 6mg loading/2mg maintenance and epacadostat 300mg BID. If 1 subject in dose level 1 (DL1) develops DLT, 3 additional subjects will be enrolled in DL1. If 2 or more subjects in a total of 6 subjects, or 2 or more subjects in the initial 3 subjects develop DLT, the next 3 subjects will be treated at dose level -1 (DL-1): 3mg loading/1mg sirolimus + epacadostat 100mg BID. If only 1 subject in a total of 6 develops DLT, dose escalation to DL2 will be made for the next 3 subjects. Same algorithm will apply to DL2 except no further dose escalation/de-escalation will be made. Sirolimus lead-in phase: loading dose on day -7 and maintenance dose starting day -6. On Cycle 1 Day 1, epacadostat 300mg BID will be added.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epacadostat

2018

Completed Phase 3

~1080

sirolimus

2006

Completed Phase 4

~1510

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Chao HuangLead Sponsor

University of Kansas Medical CenterOTHER

461 Previous Clinical Trials

169,142 Total Patients Enrolled

Chao Huang, MDPrincipal Investigator - KUMC

Jayhawk Primary Care Inc, Kansas City VA Medical Center

University Fed De Rio Grande Do Sul (Medical School)

Temple University Hospital (Residency)

3 Previous Clinical Trials

58 Total Patients Enrolled

Media Library

Epacadostat (IDO1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03217669 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Sirolimus/Epacadostat Dose Escalation, Sirolimus/Epacadostat Dose Expansion

Non-Small Cell Lung Cancer Clinical Trial 2023: Epacadostat Highlights & Side Effects. Trial Name: NCT03217669 — Phase 1

Epacadostat (IDO1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03217669 — Phase 1

Frequently Asked Questions

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

Are there precedents of research utilizing sirolimus?

"Currently, there are 137 active trials for sirolimus with 15 of those studies in their final phase. Predominantly based out of Cincinnati, Ohio, these investigations into the medication's efficacy and safety span 1,441 locations worldwide."

Answered by AI

Are there still opportunities to enroll in this research endeavor?

"This research is no longer actively seeking for participants as it was last updated on May 18th 2022. However, if you are looking to join other clinical trials, there are 1,810 active studies related to carcinoma non-small-cell lung and 137 investigations involving the drug sirolimus that require patient enrollment."

Answered by AI

What is the aggregate patient count involved in this clinical experiment?

"Unfortunately, this study is not recruiting participants at the moment. Initially posted on February 22nd 2018 and last edited on May 18th 2022, it has reached its recruitment quota. However, there are currently 1,810 studies that require patients with carcinoma non-small cell lung and 137 trials searching for volunteers to receive sirolimus."

Answered by AI

Has sirolimus achieved regulatory authorization from the FDA?

"Our team judged the safety of sirolimus to be a 1, as this is only an initial trial and there are limited data sources that support its efficacy and security."

Answered by AI