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PARP Inhibitor
Selumetinib + Olaparib for Ovarian and Endometrial Cancer
Phase 2
Recruiting
Led By Shannon N Westin
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial studies treating recurrent/persistent ovarian/endometrial cancer with RAS mutation with selumetinib+olaparib to increase tumor shrinkage & stability compared to selumetinib alone.
Who is the study for?
This trial is for women with recurrent or persistent ovarian and endometrial cancers that have RAS pathway mutations. They must have progressed after first-line treatment, not be eligible for further platinum-based therapy (for ovarian cancer), and have measurable disease. Participants need to agree to biopsies, use two forms of birth control if applicable, and meet specific health criteria including organ function tests.Check my eligibility
What is being tested?
The study compares the effectiveness of combining Selumetinib, a cell growth inhibitor, with Olaparib, a DNA repair blocker (PARP inhibitor), versus using Selumetinib alone in treating these cancers. The goal is to see if the combination better shrinks tumors or keeps them stable without progression compared to just one drug.See study design
What are the potential side effects?
Potential side effects include digestive issues; fatigue; blood disorders like anemia; vision changes due to retinal problems; lung issues such as pneumonitis; heart conditions like uncontrolled atrial fibrillation or acute coronary syndrome within recent months; high blood pressure; allergic reactions to either drug's components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Duration of response of both arms
Incidence of adverse events (AE)
ORR in crossover patients
+1 moreOther outcome measures
Concordance between the diagnostic tumor mutation profile, biopsy mutations, and pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutations
ORR
Therapeutic procedure
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (selumetinib, olaparib)Experimental Treatment8 Interventions
Patients receive selumetinib PO BID and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.
Group II: Arm II (selumetinib)Active Control7 Interventions
Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Computed Tomography
2017
Completed Phase 2
~2720
Olaparib
2007
Completed Phase 4
~2140
Selumetinib Sulfate
2017
Completed Phase 2
~80
Biospecimen Collection
2004
Completed Phase 2
~1730
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,908 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,687 Total Patients Enrolled
Shannon N WestinPrincipal InvestigatorNRG Oncology
11 Previous Clinical Trials
1,031 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.My liver is severely impaired.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have taken MEK inhibitor medications.I am enrolled in EAY191 and assigned to ComboMATCH for EAY191-N4 due to a specific mutation.I can safely undergo a biopsy or have recent tissue samples available.I am not taking vitamin E supplements above the daily recommended dose.My cancer has a RAS pathway mutation.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.My brain cancer has not worsened after treatment.My condition worsened while I was on a PARP inhibitor treatment.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I have had multiple previous treatments for my condition.My kidney function, measured by creatinine clearance, is good.I am HIV positive, on treatment, and my viral load is undetectable.I have another cancer type, but it won't affect this trial's treatment.I have been diagnosed with or show signs of MDS/AML.I have not taken Vitamin E in the week before starting selumetinib treatment.I am a man who will use condoms during the study and for 16 weeks after to prevent pregnancy.I have stopped taking certain strong or moderate drugs that affect my liver enzymes at least 14 days ago.I have ovarian cancer and cannot receive more platinum-based treatments.I finished my last cancer treatment at least four weeks ago.My hemoglobin level is at least 9.5 g/dL without recent blood transfusions.I have endometrial cancer and have been treated with or offered immunotherapy, unless I had reasons not to take it.My cancer can be measured and biopsied according to specific size guidelines.I agree to use two forms of birth control or practice abstinence during and for 12 weeks after the study.I can swallow pills and don't have stomach issues affecting medicine absorption.I have recovered from side effects of previous cancer treatments, except for hair loss.I have chronic hepatitis B but it's under control with treatment.I have not had a blood transfusion in the last 28 days.I haven't had any cancer treatments or experimental drugs in the last 4 weeks or longer.My condition worsened after the first treatment for my recurring or persistent disease.I have moderate to severe nerve pain or damage.I have at least one measurable tumor that wasn't previously treated with radiation.I am not currently using strong or moderate drugs that affect liver enzymes.I am not currently using, or have stopped using certain strong or moderate drugs that affect how other medications work, for the required time before starting olaparib.I have specific eye conditions but no significant vision loss or pain from glaucoma.My doctor says I don't need immediate brain treatment for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (selumetinib, olaparib)
- Group 2: Arm II (selumetinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are engaged in this experiment?
"Affirmative. Clinicaltrials.gov reveals that this medical trial, first posted on March 6th 2023, is actively accepting participants. A total of 165 subjects will be recruited from a single site."
Answered by AI
Are there still vacancies for participants in this clinical research?
"Indeed, clinicaltrials.gov confirms that this medical study is currently accepting enrollees. It was initially published on March 6th 2023 and has been recently revised as of March 8th 2023. This trial seeks to enroll 165 patients from a single site."
Answered by AI
Has the combination of selumetinib and olaparib received governmental sanction by the FDA?
"Our team at Power assigned Arm I (selumetinib, olaparib) a safety rating of 2 on the 1 to 3 scale. This reflects that selumetinib and olaparib have been proven safe in clinical trials but not yet effective for patients."
Answered by AI
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