DS-8201a + Olaparib for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and best dose of two drugs, DS-8201a and olaparib, in patients with certain advanced cancers. DS-8201a targets and kills cancer cells with a specific protein, and olaparib stops cancer cells from fixing their DNA. The goal is to see if these drugs can shrink or control the cancer.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take medications that are moderate or strong inhibitors or inducers of CYP3A, and if you are taking chloroquine or hydroxychloroquine, you will need a 14-day washout period (time without taking these medications) before joining the study.
Is the combination of DS-8201a and Olaparib safe for humans?
Olaparib (also known as Lynparza) has been studied for safety in various cancers, including ovarian and breast cancer. It is generally considered safe, but like all medications, it can have side effects, which may include nausea, fatigue, and anemia (low red blood cell count). There is limited specific safety data available for the combination of DS-8201a and Olaparib in endometrial cancer.12345
What makes the drug combination of DS-8201a and Olaparib unique for treating endometrial cancer?
The combination of DS-8201a and Olaparib is unique because it pairs a novel antibody-drug conjugate (DS-8201a) with a PARP inhibitor (Olaparib), which is known for its effectiveness in treating cancers with DNA repair deficiencies, like BRCA mutations. This approach targets cancer cells more precisely and may offer a new treatment option for endometrial cancer, which currently lacks many targeted therapies.15678
What data supports the effectiveness of the drug Olaparib for treating endometrial cancer?
Olaparib has shown promising results in treating ovarian cancer, particularly in patients with BRCA mutations, and is approved for use in certain types of breast cancer. This suggests it may have potential benefits for other cancers, like endometrial cancer, that share similar genetic characteristics.12369
Who Is on the Research Team?
Elizabeth Lee
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults with HER2-expressing cancers that are advanced or can't be surgically removed, and specifically includes those with endometrial cancer. Participants must have tried at least one chemotherapy before, have a good performance status, and meet certain health criteria like normal organ function tests. Pregnant women, patients with recent heart attacks or uncontrolled infections, and those on certain drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trastuzumab deruxtecan IV and olaparib PO in cycles of 21 days, with blood samples, ECHO or MUGA, and CT scans conducted throughout the trial
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- DS-8201a
- Olaparib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor