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Azeliragon + Chemotherapy for Breast Cancer (RAGE Trial)
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.
RAGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRAGE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RAGE Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I do not have any serious illnesses that would stop me from following the study's requirements.I am not taking any strong CYP2C8 inhibitors, or have stopped them as required.I have not had chemotherapy, radiotherapy, or systemic therapy for early stage breast cancer or any other cancer.I have no history of stroke, head injury, or diseases like Alzheimer's.I have had chemotherapy, radiotherapy, systemic therapy, or hormonal therapy before.My organ and bone marrow functions are normal.I have stage I-III breast cancer and will receive chemotherapy.I am not pregnant or breastfeeding.My breast cancer is at stage IV.I can take care of myself but might not be able to do heavy physical work.I have HIV, HBV, or HCV but my viral load is undetectable with treatment.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer.
- Group 1: Cohort 2: TTP488 (Azeliragon) co-administered with TC
- Group 2: Cohort 4: TTP488 (Azeliragon) co-administered with chemotherapy regimen that includes ddAC
- Group 3: Cohort 1: TTP488 (Azeliragon) co-administered with dose dense paclitaxel (ddAC/ddT)
- Group 4: Cohort 3: TTP488 (Azeliragon) co-administered with TCHP
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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