ZEN003694 + Abemaciclib for Cancer
Trial Summary
What is the purpose of this trial?
This trial tests the safety and best dose of two drugs, ZEN003694 and abemaciclib, in patients with advanced cancers. These drugs work together to stop cancer cells from growing and dividing. The goal is to find out if this combination can help treat cancers that have spread or cannot be removed by surgery.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that are strong inhibitors or inducers of certain liver enzymes (CYP3A4) at least 7 days before starting the study drugs. If you are on such medications, you will need to discuss alternatives with your doctor.
What data supports the effectiveness of the drug Abemaciclib in cancer treatment?
Abemaciclib has been shown to be effective in reducing the risk of breast cancer recurrence when combined with endocrine therapy, particularly in patients with hormone receptor-positive, HER2-negative breast cancer. It has also improved progression-free survival in advanced breast cancer when used with letrozole.12345
Is the combination of ZEN003694 and Abemaciclib safe for humans?
Abemaciclib, used in various breast cancer treatments, is generally considered safe with manageable side effects like diarrhea, infections, and low white blood cell counts. While specific safety data for the combination with ZEN003694 is not provided, Abemaciclib's safety profile in other treatments suggests it is tolerable.12567
What makes the drug combination of ZEN003694 and Abemaciclib unique for cancer treatment?
The combination of ZEN003694 and Abemaciclib is unique because it involves a novel pairing of a CDK4/6 inhibitor (Abemaciclib) with another agent (ZEN003694), potentially offering a new approach to targeting cancer cell growth and division, especially in cases where standard treatments may not be effective.158910
Eligibility Criteria
This trial is for adults and kids aged 12-17 with NUT carcinoma or other solid tumors that have spread or can't be surgically removed. Participants need to meet specific health criteria, like normal organ function tests, controlled HIV or hepatitis if present, and a certain level of physical fitness. They should not have untreated brain metastases or conditions that could affect the trial's results.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ZEN003694 and abemaciclib orally in 28-day cycles, with imaging evaluation, blood sample collection, and tumor biopsy throughout the study
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Abemaciclib (CDK4/6 Inhibitor)
- ZEN003694 (BET Bromodomain Inhibitor)
Abemaciclib is already approved in United States, European Union for the following indications:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer