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Palbociclib + Gedatolisib for Solid Cancers
Study Summary
This trial is testing a combination of drugs to see if they can treat cancer that has a specific change in the PI3K pathway.
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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- My cancer has spread, can't be surgically removed, and doesn't respond to standard treatments.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I have had chemotherapy or radiotherapy recently.I am currently using or might need specific medications or special foods.I do not have brain metastases needing treatment.I have cancer that can be evaluated but not measured for Part I, or cancer that can be measured for Part II.My cancer is advanced and either affects the lung, pancreas, head & neck, or is linked to the PI3K-pathway.I agree to use birth control during the study.My organ and bone marrow functions are normal.I do not have any unmanaged ongoing illnesses.I have a history of diabetes.I am not using, nor do I plan to use, certain medications.I am not taking proton pump inhibitors with palbociclib.I have a history of heart conditions or abnormal heart rhythm.I am currently taking medication that can affect my heart's rhythm.I have had previous treatments for my condition.I do not have any serious infections right now.
- Group 1: Combination Of Palbociclib and Gedatolisib
- 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
How many volunteers are contributing to this scientific endeavor?
"Affirmative, the clinicaltrials.gov website alludes to this medical study's current recruitment status. Initially posted on February 28th 2017, it has since undergone a recent update on January 18th 2022 with plans of enrolling 96 patients at 3 distinct sites."
In what circumstances is Palbociclib typically prescribed?
"Palbociclib is often employed to treat breast cancer, but can also be useful when managing malignant neoplasms, advanced directives and postmenopausal issues."
Are there any available slots for prospective participants in this research project?
"This particular clinical trial is presently enrolling patients; its initial posting was on February 28th 2017 and the latest amendment was made January 18th 2022."
Has the FDA sanctioned Palbociclib for medical use?
"The safety of Palbociclib is assessed to be a 1, since this Phase 1 trial has only little evidence backing its effectiveness and security."
Is Palbociclib an experimental medicine for which prior research has taken place?
"As of the present moment, there are 134 active clinical trials for Palbociclib with 16 in Phase 3. These studies primarily occur in Burgas, New jersey; yet there is a total 6582 sites where research on this drug is being conducted."
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