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Azeliragon + Chemotherapy for Breast Cancer (RAGE Trial)

Phase 1 & 2
Recruiting
Led By Candace Mainor, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years.
Patients must have had no prior chemotherapy/radiotherapy/or systemic therapy for early stage breast cancer, or any other malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort 1 and 4: cycle 3 and cycle 4, day 1 and day 2 of 14 day cycle; cohort 2 and 3:cycle 5 and cycle 6, day 1 and day 2 of 21 day cycle
Awards & highlights

RAGE Trial Summary

This trial is testing if a new drug, azeliragon, is safe to take with chemotherapy. The Investigators think there will be no problems taking the two together.

Who is the study for?
This trial is for women with early-stage breast cancer (stage I-III) who are about to start chemotherapy and have not had previous treatments for any cancer. They must be over 18, have good organ function, no severe neurological or psychiatric conditions that could affect consent, and agree to use contraception. HIV-positive patients on effective therapy can join.Check my eligibility
What is being tested?
The study tests azeliragon's ability to reduce heart damage from certain chemotherapies (TCHP, ddAC/ddT, TC) and its safety when combined with these treatments. It aims to see if blocking the RAGE pathway lessens heart toxicity and cognitive decline caused by chemotherapy.See study design
What are the potential side effects?
While specific side effects of azeliragon in combination with chemotherapy aren't detailed here, potential risks include those commonly associated with chemo such as fatigue, nausea, increased infection risk; plus any unknown risks of azeliragon itself.

RAGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have not had chemotherapy, radiotherapy, or systemic therapy for early stage breast cancer or any other cancer.
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I have no history of stroke, head injury, or diseases like Alzheimer's.
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My organ and bone marrow functions are normal.
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I have stage I-III breast cancer and will receive chemotherapy.
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I can take care of myself but might not be able to do heavy physical work.
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I have HIV, HBV, or HCV but my viral load is undetectable with treatment.

RAGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 1 and 4: cycle 3 and cycle 4, day 1 and day 2 of 14 day cycle; cohort 2 and 3:cycle 5 and cycle 6, day 1 and day 2 of 21 day cycle
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort 1 and 4: cycle 3 and cycle 4, day 1 and day 2 of 14 day cycle; cohort 2 and 3:cycle 5 and cycle 6, day 1 and day 2 of 21 day cycle for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Incidence of chemotherapy dose interruption, dose modification, dose discontinuation
Incidence of severe AE graded according to the CTCAE v.5
+1 more
Secondary outcome measures
Pharmacokinetic (PK) assessment: AUC0-INF
Pharmacokinetic (PK) assessment: AUC0-last
Pharmacokinetic (PK) assessment: AUC0-tau
+3 more

RAGE Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: TTP488 (Azeliragon) co-administered with chemotherapy regimen that includes ddACExperimental Treatment2 Interventions
given at the end of the chemotherapy plan [can include: (1)weekly carboplatin + paclitaxel + pembrolizumab followed by pembrolizumab + dose dense doxorubicin and cyclophosphamide; (2) weekly carboplatin + paclitaxel followed by dose dense doxorubicin and cyclophosphamide; (3) weekly or dose dense paclitaxel followed by dose dense doxorubicin and cyclophosphamide] Cohort 4: On day 7 of cycle 3, twelve capsules of azeliragon taken daily for 6 days, and then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 4 Day 2 (C4D2).
Group II: Cohort 3: TTP488 (Azeliragon) co-administered with TCHPExperimental Treatment2 Interventions
TCHP: docetaxel, carboplatin, trastuzumab, and pertuzumab Cohort 3: Cycle 5 Day 14 (C5D14), take twelve capsules of azeliragon daily for 6 days, then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 6 Day 2 (C6D2).
Group III: Cohort 2: TTP488 (Azeliragon) co-administered with TCExperimental Treatment2 Interventions
TC: docetaxel and cyclophosphamide Cohort 2a (6 cycles): Cycle 5 Day 14 (C5D14), take twelve capsules of azeliragon daily for 6 days, then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 6 Day 2 (C6D2). Cohort 2b (4 cycles): Cycle 3 Day 14 (C3D14), take twelve capsules of azeliragon daily for 6 days, then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 4 Day 2 (C4D2).
Group IV: Cohort 1: TTP488 (Azeliragon) co-administered with dose dense paclitaxel (ddAC/ddT)Experimental Treatment2 Interventions
Cohort 1: On day 7 of cycle 3, twelve capsules of azeliragon taken daily for 6 days, and then four capsules of Azeliragon each day continuously through the end of that cycle of chemotherapy, extending into Cycle 4 Day 2 (C4D2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TC
2002
Completed Phase 3
~1750

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,454 Total Patients Enrolled
Candace Mainor, MDPrincipal InvestigatorGeorgetown University
3 Previous Clinical Trials
73 Total Patients Enrolled

Media Library

Chemotherapy regimen that includes ddAC Clinical Trial Eligibility Overview. Trial Name: NCT05256745 — Phase 1 & 2
Cancer-Related Cognitive Impairment Research Study Groups: Cohort 2: TTP488 (Azeliragon) co-administered with TC, Cohort 4: TTP488 (Azeliragon) co-administered with chemotherapy regimen that includes ddAC, Cohort 1: TTP488 (Azeliragon) co-administered with dose dense paclitaxel (ddAC/ddT), Cohort 3: TTP488 (Azeliragon) co-administered with TCHP
Cancer-Related Cognitive Impairment Clinical Trial 2023: Chemotherapy regimen that includes ddAC Highlights & Side Effects. Trial Name: NCT05256745 — Phase 1 & 2
Chemotherapy regimen that includes ddAC 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256745 — Phase 1 & 2

Frequently Asked Questions

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

Can people with the relevant medical condition enroll in this trial at this time?

"According to the details available on clinicaltrials.gov, this particular trial is not presently looking for patients as it has already completed recruitment. This information is corroborated by the dates listed on the site; the study was first posted on November 1st, 2022 and was last updated almost two months ago on September 27th, 2022. There are 2949 other trials that are still recruiting right now though."

Answered by AI

What are we hoping to learn from this research?

"The primary goal of this clinical trial, as measured over a 14 or 21 day period depending on the cohort, is to track the incidence of toxicity. The study will also collect data on how different doses of the medication affect patients' maximum concentration levels and how long it takes for the patient to reach that maximum level."

Answered by AI
~21 spots leftby Nov 2024