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Ribociclib + Belinostat for Breast Cancer (CHARGE Trial)
CHARGE Trial Summary
This trial is designed to assess the maximum tolerated dose of two drugs, ribociclib and belinostat, in combination. The trial will start with a dose escalation, followed by an expansion cohort at the identified dose. Dose escalation will be open to patients with triple-negative breast cancer or ovarian cancer. Dose expansion will only be open to patients with triple-negative breast cancer.
CHARGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCHARGE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CHARGE Trial Design
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Who is running the clinical trial?
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- I am not allergic to belinostat, ribociclib, or their components.I have brain metastases or leptomeningeal disease but don't need immediate brain-specific treatment.I am not using herbal supplements or they are approved by the study lead.I have a digestive issue that affects how my body absorbs medication.You have a long-term infection with hepatitis B virus (HBV) or hepatitis C virus, and there are detectable levels of the virus in your blood.I can take care of myself but might not be able to do heavy physical work.I haven't had major surgery or cancer treatment in the last 4 weeks.I agree to have up to 3 biopsies on areas where my cancer has spread.I am not taking any strong medication that affects liver enzymes or blood thinners like warfarin.My breast cancer has specific features confirmed by a pathology report.I have HIV with a detectable viral load in the last 6 months.I do not have uncontrolled heart rhythm problems, heart failure, or chest pain.My breast cancer has been confirmed with specific features for dose escalation.I am 18 years old or older.Women who can have babies need to have a negative pregnancy test before joining the study.My ovarian cancer has returned, cannot be surgically removed, and is of the serous type.I have a cancer other than breast or ovarian that might need treatment within a year.My blood, liver, and kidney functions are within normal ranges.I might need valproic acid soon or while on the study.I do not have serious heart rhythm problems or a long QT syndrome.I have ongoing moderate to severe diarrhea.My heart's pumping ability is below normal.I have used CDK 4/6 or HDAC inhibitors for my cancer.I am currently on medication for an infection.I am currently taking medication that affects UGT1A1.I can swallow pills.I am not taking medication known to cause heart rhythm problems.
- Group 1: Treatment: all patients
- 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
Has there previously been research conducted on Ribociclib?
"Ribociclib was first studied at Azienda Ospedaliera Universitaria Federico II in 2012 and there are currently 58 concluded trials. Of the 55 active studies, many of them take place near Fairfax, Virginia."
In what medical circumstances is Ribociclib typically prescribed?
"Ribociclib is chiefly given to those with refractory peripheral t-cell lymphoma unspecified. It has also proven effective for malignant neoplasms, postmenopause, and relapsed peripheral t-cell lymphoma cases."
How many participants are expected to be recruited for this trial?
"Affirmative, the clinicaltrials.gov records demonstrate that this research is recruiting volunteers at present. The trial was originally posted on May 3rd 2021 and has been updated most recently on May 3rd 2022. 34 subjects are required from 2 sites in total."
Has the Federal Drug Administration certified Ribociclib for therapeutic applications?
"As a phase 1 trial, there is limited data available on the safety and efficacy of ribociclib. Therefore, our team has assigned it a score of 1/3."
Is this trial the inaugural effort of its kind?
"As of now, 55 clinical trials related to Ribociclib are taking place in 447 cities and 48 nations. The first trial commenced eight years ago with the sponsorship of Pfizer and included 189 test subjects. With 58 studies already finished since then, ample data regarding this medication has been amassed."
Are participants currently being enrolled for this medical experiment?
"As per clinicaltrials.gov, this medical study is actively in search of volunteers and was initially established on May 3rd 2021 before being revisited on the same date a year later."
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