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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 belowSelect...
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:Select...
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)
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
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Olaparib
2007
Completed Phase 4
~2190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,996 Total Patients Enrolled
289 Trials studying Ovarian Cancer
76,483 Patients Enrolled for Ovarian Cancer
Camille GundersonPrincipal InvestigatorYale University Cancer Center LAO
Camille JacksonPrincipal InvestigatorYale University Cancer Center LAO
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