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CDK4/6 Inhibitor

Abemaciclib + Olaparib for Recurrent Ovarian Cancer

Phase 1

Recruiting

Led By Camille Gunderson

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

ECOG performance status =< 2 (Karnofsky >= 60%)

GFR >= 60 mL/min/1.73 m^2 (within 28 days prior to administration of study treatment)

Must not have

Myelodysplastic syndrome/acute myeloid leukemia or features suggestive of MDS/AML

Major surgery within 2 weeks of starting study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days (end of cycle 1)

Awards & highlights

No Placebo-Only Group

Summary

This trialtests if adding abemaciclib to olaparib could help treat ovarian cancer that has come back after platinum-based drugs.

Who is the study for?

This trial is for women over 18 with recurrent platinum-resistant ovarian cancer, who've had 1-3 prior treatments but no CDK 4/6 inhibitors. They must not be pregnant or breastfeeding, have a good performance status, and agree to contraception. Exclusions include certain medical conditions, recent major surgery, active infections, and known allergies to the drugs tested.

What is being tested?

The study tests combining abemaciclib (which blocks enzymes needed for cell growth) with olaparib (a PARP inhibitor preventing tumor DNA repair) in patients whose ovarian cancer has returned after initial treatment success. The goal is to find the safest dose of abemaciclib that works best with olaparib.

What are the potential side effects?

Potential side effects may include fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems. There could also be liver issues indicated by abnormal blood tests and possible allergic reactions related to drug components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may not be able to do active work.

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My kidney function is good.

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My hepatitis C is either cured or undetectable.

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My hepatitis B virus load is undetectable with treatment.

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My heart function is classified as NYHA 2B or better.

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My ovarian cancer has come back and does not respond to platinum-based treatments.

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I can take care of myself but might not be able to do heavy physical work.

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I have had 1 to 3 treatments for my condition before.

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I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a blood disorder that could be or is turning into leukemia.

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I have not had major surgery in the last 2 weeks.

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I have an ongoing fungal infection in my body.

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I have had a bone marrow or double cord blood transplant.

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I am not taking strong or moderate drugs that affect liver enzyme CYP3A.

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I currently have a blood clot.

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I have heart conditions that are not under control.

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I have a serious health condition that is not under control.

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I have or might have lung scarring or inflammation.

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I am allergic to abemaciclib, olaparib, or their ingredients.

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I cannot swallow pills or have stomach issues affecting medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days (end of cycle 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days (end of cycle 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days (end of cycle 1) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Recommended phase 2 dose (RP2D)

Secondary study objectives

Duration of response (DoR)

Overall response rate (ORR)

Other study objectives

Biomarker analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (abemaciclib, olaparib, biospecimen collection)Experimental Treatment4 Interventions

Patients receive olaparib PO BID on days 1-28 and abemaciclib PO BID on days 8-28 of cycle 1 and days 1-28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo tumor biopsy on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

Biopsy

2014

Completed Phase 4

~1150