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Palbociclib for Brain Metastasis
Study Summary
This trial is looking at whether the drug palbociclib can help treat brain cancer that has come back.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT03007979Trial Design
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Who is running the clinical trial?
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- I have been treated with a CDK4/6 inhibitor before.I have stable levels of body salts and minerals.I am currently taking medication that can affect my heart's rhythm.I have a brain lesion that is at least 10 mm big.I have recently undergone chemotherapy, immunotherapy, or radiotherapy.I have a heart condition related to abnormal heart rhythms.My cancer diagnosis was confirmed through tissue or cell analysis.I can care for myself but may not be able to do active work.I have had a brain surgery or biopsy for genetic testing.My brain cancer is getting worse despite previous treatments.My cancer has a CDK pathway mutation.I have been on a steady dose of corticosteroids for at least a week.I am HIV-positive and on combination antiretroviral therapy.My cancer outside the brain is getting worse but I can still participate.I am taking medication that affects liver enzymes.I am 18 years old or older.I am not currently on any other cancer treatments.I do not have any uncontrolled illnesses.My blood tests for organ and bone marrow function are normal.My cancer has spread to the lining of my brain and spinal cord.
- Group 1: Palbociclib
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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
To what extent can Palbociclib help patients with ____ cancer?
"Palbociclib is effective in the treatment of breast, malignant neoplasms, and postmenopausal patients."
Does Palbociclib have a high potential for patient harm?
"Given that this is a phase 2 trial, meaning there is only some data supporting safety and none yet for efficacy, our team has estimated the safety of Palbociclib to be a 2."
Are there any other completed or ongoing studies of Palbociclib's effects?
"As of right now, 139 separate clinical trials are ongoing for Palbociclib. Of those, 17 are in their third and final Phase. Most of the research being conducted on Palbociclib is based out of Burgas, New jersey; however 6640 different medical facilities worldwide are running similar studies."
Are patients still being enrolled in this research project?
"Indeed, this clinical trial is still recruiting patients as per the information on clinicaltrials.gov. 30 individuals are needed for the study which began on November 1st, 2016 and was most recently updated on October 25th, 2021. The recruitment process will take place at 2 different sites."
To date, how many people have signed up for this clinical trial?
"That is correct, the listing on clinicaltrials.gov does show that this research project requires new participants. The study was first advertised on November 1st, 2016 and updated most recently on October 25th, 2021. There are 30 positions available at 2 different locations."
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