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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
Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment
Cohort 1: Patients with histologically confirmed RAS pathway mutant ovarian cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a RAS pathway mutation.
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My ovarian cancer has a confirmed RAS pathway mutation.
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My endometrial cancer has a confirmed RAS pathway mutation.
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I can safely undergo a biopsy or have recent tissue samples available.
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My condition worsened after the first treatment for my recurring or persistent disease.
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I have ovarian cancer and cannot receive more platinum-based treatments.
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I have endometrial cancer and have been treated with, or offered, immunotherapy.
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I have had multiple previous treatments for my condition.
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I have a tumor that can be measured and biopsied.
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My cancer has a RAS pathway mutation.
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My ovarian cancer has a RAS pathway mutation.
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My endometrial cancer has a RAS pathway mutation.
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My condition worsened after the first treatment for my recurring or persistent disease.
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I have ovarian cancer and cannot receive more platinum-based treatments.
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I have endometrial cancer and was offered or received immunotherapy.
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My cancer can be measured and biopsied according to RECIST 1.1.
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I have more than one detectable cancer lesion.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I can swallow pills and don't have stomach issues affecting medicine absorption.
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My heart health is assessed as moderate risk or better.
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I am a man (or my partner is a woman of childbearing potential) and we use birth control.
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I am HIV-positive, on effective treatment, and my viral load is undetectable.
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My hepatitis B virus is undetectable with my current treatment.
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My hepatitis C is either cured or undetectable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Other outcome measures
Concordance between the diagnostic tumor mutation profile, biopsy mutations, and pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutations
ORR
Therapeutic procedure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Biopsy
2014
Completed Phase 4
~1160
Biospecimen Collection
2004
Completed Phase 1
~1850
Computed Tomography
2017
Completed Phase 2
~2710
Echocardiography
2013
Completed Phase 4
~11670
Olaparib
2007
Completed Phase 4
~2140
Selumetinib Sulfate
2017
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,579 Previous Clinical Trials
41,224,331 Total Patients Enrolled
75 Trials studying Endometrial Cancer
72,673 Patients Enrolled for Endometrial Cancer
NRG OncologyOTHER
230 Previous Clinical Trials
100,489 Total Patients Enrolled
2 Trials studying Endometrial Cancer
395 Patients Enrolled for Endometrial Cancer
Shannon N WestinPrincipal InvestigatorNRG Oncology
11 Previous Clinical Trials
1,031 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05554328 — Phase 2
Endometrial Cancer Research Study Groups: Arm I (selumetinib, olaparib), Arm II (selumetinib)
Endometrial Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT05554328 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05554328 — Phase 2

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
~68 spots leftby Sep 2024