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DS-8201a + Olaparib for Endometrial Cancer
Study Summary
This trial is testing the side effects and best dose of two drugs, DS-8201a and olaparib, in treating patients with HER2-expressing cancers. Olaparib is a drug that blocks an enzyme involved in many cell functions, including the repair of deoxyribonucleic acid (DNA) damage. DS-8201a is an antibody-drug conjugate. This agent has two components: an antibody component and a chemotherapy component. The antibody component is attached to the chemotherapy molecules. Upon administration of DS-8201a, the antibody targets and binds to tumor cells that have abundant HER2 (
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.Trial Design
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- I have a preserved tissue sample for HER2 testing.I have had at least one round of chemotherapy before.I have a confirmed diagnosis of uterine serous carcinoma and at least one tumor that can be safely biopsied.You have experienced allergic reactions to similar drugs or compounds like DS-8201a, olaparib or monoclonal antibodies.My cancer has some level of HER2 expression or amplification.I haven't had any blood or platelet transfusions in the last week.My heart's pumping ability is normal, confirmed by a recent heart scan.I will not donate or use my own eggs for 7 months after the last study drug.My tumor is HER2-positive, confirmed by a certified lab.I have a preserved tissue sample available for HER2 testing.My kidney function tests are within the required range.My hepatitis C is cured or currently undetectable.I have another cancer type, but it won't affect this cancer treatment.I agree to use effective birth control during and for 7 months after the study.My heart condition is not severe and is classified better than class 2B.I have side effects from cancer treatment that haven't improved to mild or gone back to how they were before treatment.I have or had lung inflammation that needed steroids, or it can't be ruled out by scans.I agree not to donate or freeze sperm during and for 4 months after the study.I am a woman who cannot become pregnant due to surgery or menopause.I am HIV-positive, on stable treatment, with no recent severe infections.I am 18 years old or older.I haven't received G-CSF treatment in the last week.I haven't had a heart attack or severe heart failure in the last 6 months.I have severe lung problems due to other illnesses or autoimmune conditions.My cancer shows some level of HER2 protein or gene amplification.My brain metastases are stable, I'm not on steroids, and it's been 4 weeks since my last radiation.I have received chemotherapy before.I am participating in the initial phase of a trial where doses are increased.I have not had radiation therapy in the last 4 weeks.I have previously taken PARP inhibitors.I haven't taken chloroquine or hydroxychloroquine in the last 14 days.I had major surgery less than 4 weeks ago.I am participating in either the dose escalation or expansion phase of a trial.I have had multiple treatments for my condition, including chemotherapy and targeted therapy.I do not have an infection needing IV drugs.I haven't had chemotherapy in the last 4 weeks, with some exceptions.My hepatitis B virus load is undetectable with treatment.You are currently taking part in another study with experimental medication.I am mostly able to care for myself and perform daily activities.I am not taking any strong or moderate drugs that affect liver enzymes.My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.I have a type of uterine cancer that can be safely biopsied.My cancer can be measured or evaluated using specific criteria.I am in the dose expansion phase of treatment.I have not had any cancer except for non-melanoma skin cancer, in-situ disease, or other solid tumors that were completely removed or treated.
- Group 1: Treatment (trastuzumab deruxtecan, olaparib)
- 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
What end-goals are researchers hoping to achieve with this clinical investigation?
"This clinical trial will assess the occurrence of adverse events over a span of 42 days as its primary outcome. Secondary outcomes include evaluating Clinical Benefit Rate (CBR) using RESIST 1.1 criteria, examining Plasma Pharmacokinetic (PK) profiles through descriptive statistics and analysis of variance, and measuring Markers of Deoxyribonucleic Acid (DNA) damage response with multiplex Immunofluorescence in tumour samples during treatment for the dose expansion cohort to correlate these markers with responses."
Is this research pioneering in its field?
"Since first being trialled in 2005, sponsored by AstraZeneca and involving 98 participants, Trastuzumab Deruxtecan has been analyzed more extensively. This resulted in the drug receiving Phase 1 approval following its initial study. Nowadays, there are 222 active trials of this medication across 1679 cities and 61 nations worldwide."
Does this investigation still have openings for participants?
"Affirmative. According to clinicaltrials.gov, this trial was initially posted on the 4th of January 2021 and has been actively recruiting 55 participants across four sites since its last update in October 26 2022"
How is Trastuzumab Deruxtecan typically utilized to treat patients?
"The usual course of pharmacotherapy for this condition involves treatment with Trastuzumab Deruxtecan, which can also be effective when managing breast cancer, primary peritoneal cancer and a range of somatic hallucinations."
What additional research has been conducted regarding the efficacy of Trastuzumab Deruxtecan?
"Trastuzumab Deruxtecan was initially studied in 2005 at a Research Site. Since then, 113 clinical studies have been completed and 222 trials are presently enrolling patients with many of them being conducted out of Rochester, Minnesota."
Has the federal regulator approved Trastuzumab Deruxtecan for public use?
"Due to the limited data available on Trastuzumab Deruxtecan, there is only a tentative score of 1 when considering its safety profile. This figure reflects that this drug is still in Phase 1 trials, indicating insufficient evidence for efficacy and safety."
What number of medical facilities are administering this clinical trial?
"Mayo Clinic in Rochester, Mayo Clinic in Florida located in Jacksonville, and Dana-Farber Cancer Institute situated in Boston are among the 4 available clinical trial sites. There is also a selection of other locations where patients can take part."
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