Study on Palbociclib for Treating Cancers with CDK4 or CDK6 Gene Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06390839
This clinical trial is testing how well the drug Palbociclib works in treating patients with cancers that have specific genetic changes in the CDK4 or CDK6 genes. Palbociclib is a type of medication that blocks signals telling cancer cells to grow, potentially slowing or stopping the spread of cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to see if Palbociclib can effectively treat cancers that have certain genetic changes in the CDK4 or CDK6 genes. These changes can cause cancer cells to multiply. Palbociclib works by blocking these signals, which may help slow down or stop the growth of cancer cells. The study will involve taking Palbociclib by mouth daily for 21 days in a 28-day cycle, with regular check-ups and scans to monitor progress.
Description
The main goal of this study is to find out how many patients experience a reduction in their cancer after taking Palbociclib. Researchers also want to see how many patients are still alive and have not had their cancer worsen after six months of treatment. They will also look at how long it takes for the cancer to progress or for the patient to pass away. Additionally, the study will explore other factors that might predict how well the treatment works, using various tests and imaging techniques.
Participants will take Palbociclib by mouth once a day for 21 days, followed by a 7-day break, in a cycle that repeats every 28 days. This will continue as long as the cancer does not progress and the patient can tolerate the treatment. Throughout the study, participants will have CT or MRI scans and provide blood samples. Some may also have a biopsy.
After finishing the treatment, participants will have follow-up visits every three months for two years, then every six months for one year.
Eligibility Criteria
Inclusion Criteria
- Must meet the eligibility criteria from the main MATCH Protocol before joining this study.
- Must have specific genetic changes in the CDK4 or CDK6 genes, as identified by the MATCH Protocol.
- Must have a recent ECG test showing no major heart rhythm issues.
- Cannot have breast cancer, mantle cell lymphoma, myeloma, or liposarcoma.
- Cannot be allergic to Palbociclib or similar drugs.
- Cannot have heart problems related to the left side of the heart.
- Cannot have previously taken CDK4 or CDK6 inhibitors like Palbociclib.
- Cannot be taking certain medications or foods that affect how Palbociclib works.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.