Palbociclib for Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use drugs or foods that strongly affect CYP3A4, an enzyme that processes many medications. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Palbociclib (Ibrance) for cancer?
Palbociclib, when used with other treatments like letrozole or fulvestrant, has been shown to significantly extend the time patients live without their cancer getting worse in cases of advanced breast cancer. It is particularly effective for hormone receptor-positive, HER2-negative breast cancer, and maintains patients' quality of life while doubling the effectiveness of other treatments.12345
What makes the drug Palbociclib unique for cancer treatment?
Palbociclib is unique because it is an oral drug that specifically targets and inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), which are proteins that help cancer cells grow. This makes it different from other treatments as it can be combined with hormone therapies like letrozole or fulvestrant to enhance their effectiveness in treating certain types of breast cancer.12345
What is the purpose of this trial?
This trial tests palbociclib, a medication taken by mouth, in patients with advanced cancers that have specific genetic changes. It works by blocking proteins needed for cancer cell growth. Researchers hope it will shrink the cancer or stop it from growing.
Research Team
Amy S Clark
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
This trial is for patients with cancers that have specific genetic changes called CCND1, 2, or 3 amplification. They must not have breast cancer, mantle cell lymphoma or myeloma and should not be on certain drugs affecting heart rhythm. Prior treatment with CDK4/6 inhibitors disqualifies them.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive palbociclib orally once daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.
Treatment Details
Interventions
- Palbociclib
Palbociclib is already approved in United States, European Union, Canada, Japan for the following indications:
- HR-positive, HER2-negative advanced or metastatic breast cancer
- HR-positive, HER2-negative locally advanced or metastatic breast cancer
- HR-positive, HER2-negative advanced or metastatic breast cancer
- HR-positive, HER2-negative advanced or recurrent breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor