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Evexomostat + Alpelisib + Fulvestrant for Breast Cancer (Amelia-1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by SynDevRx, Inc.

Eligibility Criteria Checklist

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

Must have

Patient has identified PIK3CA mutation status using a FDA-approved test, as determined either during Screening or was previously determined to have the mutation as evidenced by written documentation.

Patient has an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Amelia-1 Trial Summary

This trial looks at how a combination of 3 drugs (alpelisib, fulvestrant and evexomostat) can reduce hyperglycemia in patients with breast cancer, reducing the need for anti-diabetic meds and improving efficacy of alpelisib.

Who is the study for?

This trial is for adult women with advanced HR+/HER2- breast cancer, specifically those who have a PIK3CA mutation and are postmenopausal. Participants should not have brain malignancies or sensitivities to the drugs being tested, nor should they have uncontrolled diabetes or previous treatments with similar drugs.Check my eligibility

What is being tested?

The study tests a combination of three drugs: Evexomostat, Alpelisib, and Fulvestrant in women with a specific gene mutation linked to aggressive breast cancer. It aims to see if Evexomostat can reduce high blood sugar caused by Alpelisib and improve its effectiveness against tumors.See study design

What are the potential side effects?

Common side effects from Evexomostat include fatigue, decreased appetite, constipation, nausea, and diarrhea. The combination treatment may also cause hyperglycemia (high blood sugar), which this trial seeks to manage.

Amelia-1 Trial Eligibility Criteria

Inclusion Criteria

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

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My cancer has a PIK3CA mutation confirmed by an FDA-approved test.

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I am fully active or can carry out light work.

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My cancer can be measured by scans or I have a specific type of bone lesion.

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My breast cancer is advanced and cannot be cured with surgery or radiation.

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My breast cancer is hormone receptor positive and HER2 negative.

Amelia-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 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

Hyperglycemic Events

Incidence of Adverse Events

Secondary outcome measures

Adiponectin activity

Angiogenic activity (VEGFC)

Pathologic Neovascularization

+4 more

Amelia-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: EvexomostatExperimental Treatment1 Intervention

Each subject will receive repeat doses (C1, C2…) for 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SynDevRx, Inc.Lead Sponsor

2 Previous Clinical Trials

87 Total Patients Enrolled

1 Trials studying Breast Cancer

55 Patients Enrolled for Breast Cancer

Neal Salomon, MDStudy DirectorSynDevRx, Inc.

1 Previous Clinical Trials

32 Total Patients Enrolled

Media Library

Evexomostat Clinical Trial Eligibility Overview. Trial Name: NCT05455619 — Phase 1 & 2

Breast Cancer Research Study Groups: Evexomostat

Breast Cancer Clinical Trial 2023: Evexomostat Highlights & Side Effects. Trial Name: NCT05455619 — Phase 1 & 2

Evexomostat 2023 Treatment Timeline for Medical Study. Trial Name: NCT05455619 — Phase 1 & 2

Frequently Asked Questions

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

What is the prime objective of this investigation?

"This clinical trial, lasting up to 48 months, is primarily focused on monitoring Hyperglycemic Events. Secondary objectives include tracking Insulin Resistance using the HOMA-IR score (Fasting Serum Insulin × Fasting Plasma Glucose/22.5), Angiogenic Activity via VEGFC biomarkers and Adiponectin Activity with fasting adiponectin levels."

Answered by AI

Is this experiment welcoming new participants?

"Affirmative. Clinicaltrials.gov data supports the assertion that this trial is still recruiting participants, which initially began on August 26th 2022 and had its most recent edit made in October 21st of the same year. This research requires 52 individuals to join between 4 different sites."

Answered by AI

Are there multiple medical facilities currently conducting this research within the city boundaries?

"As it stands, there are 4 distinct clinical centres engaging in the recruitment process. These facilities can be found in Loma Linda, Toledo and Los Angeles as well as an additional four locations. For those who qualify to participate, it is wise to choose a nearby site; limiting travel requirements."

Answered by AI

How many participants have volunteered for this clinical trial?

"To successfully implement this research trial, SynDevRx Inc. must recruit a total of 52 patients that meet the established inclusion criteria. These individuals will be sourced from places such as Loma Linda University Cancer Center in California and Toledo Clinic Cancer Center in Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evexomostat Plus Alpelisib and Fulvestrant in Women With the PIK3CA Mutation With HR+/Her2- Breast Cancer

2022. "Evexomostat Plus Alpelisib and Fulvestrant in Women With the PIK3CA Mutation With HR+/Her2- Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05455619.

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