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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days (end of cycle 1)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase 2 dose (RP2D)
Secondary outcome measures
Duration of response (DoR)
Overall response rate (ORR)
Other outcome measures
Biomarker analysis

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
~1710
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,987 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Camille GundersonPrincipal InvestigatorYale University Cancer Center LAO
Camille JacksonPrincipal InvestigatorYale University Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment currently open?

"According to the clinicaltrials.gov website, this research project is still recruiting participants; it was first posted on February 12th 2021 and underwent its latest edit on November 23rd 2022."

Answered by AI

What prior experiments have included abemaciclib, olaparib and biospecimen collection in the protocol?

"Abemaciclib, olaparib, and biospecimen collection treatment was first initiated in 2005 at a research site; 139 trials have since been completed. Currently there are 276 studies recruiting participants across the United States of America with many based out of Chicago."

Answered by AI

What medical conditions commonly require abemaciclib, olaparib and biospecimen collection to be prescribed?

"Pharmacotherapy, which includes the use of abemaciclib and olaparib alongside biospecimen collection, is a useful treatment for conditions such as high risk of recurrence, primary peritoneal cancer, and even hallucinations or somatic issues."

Answered by AI

What is the scale of involvement in this medical research project?

"Affirmative. Per the clinicaltrials.gov database, this clinical trial is actively recruiting volunteers since its initial posting on February 12th 2021 and subsequent update in November 23rd 2022. Altogether, there are 8 sites looking for 42 participants."

Answered by AI

Does the FDA sanction treatment with abemaciclib, olaparib, and biospecimen collection?

"Due to the limited safety and efficacy data available, our team at Power estimated Treatment (abemaciclib, olaparib & biospecimen collection) with a score of 1."

Answered by AI

Has a trial such as this ever been attempted before?

"At the moment, there are 276 active clinical trials involving abemaciclib, olaparib and biospecimen collection being conducted in over 2000 towns and 61 countries. The initial study was initiated by AstraZeneca back in 2005 with a cohort of 98 patients that successfully passed Phase 1 drug approval; since then an additional 139 trials have been completed."

Answered by AI

Where are the sites for this experiment being conducted?

"Northwestern University in Chicago, NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Centre in New york, and Ohio State University's Comprehensive Cancer Centre in Columbus are all recruiting patients. Additionally, 8 other medical locations across the United States of America will be enrolling participants for this trial."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Oklahoma Health Sciences Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
2021. "Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04633239.
All > Recurrent Ovarian Cancer
~7 spots leftby Dec 2024
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