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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

No Placebo-Only Group

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.

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.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Duration of response of both arms

Incidence of adverse events (AE)

ORR in crossover patients

+1 more

Other study objectives

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

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030