Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04633239
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Ovarian High Grade Serous Adenocarcinoma
  • Recurrent Platinum-Resistant Ovarian Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Given PO
  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Olaparib — DRUG
    Given PO

Study Details

This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.

Key Dates

Start date
Jul 2, 2021
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (abemaciclib, olaparib, biospecimen collection)
    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.

Primary Outcome Measure

Recommended phase 2 dose (RP2D) [ Time Frame: 28 days (end of cycle 1) ]

Locations (27)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612
Site Public Contact
[email protected]
877-827-8839
Sami Dwabe (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033
Site Public Contact
[email protected]
323-865-0451
Anastasia Martynova (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Site Public Contact
323-865-0451
Anastasia Martynova (PRINCIPAL_INVESTIGATOR)
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Site Public Contact
[email protected]
877-827-8839
Sami Dwabe (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
Northwestern UniversityChicagoIllinois60611-
University of Kansas Clinical Research CenterFairwayKansas66205
Site Public Contact
[email protected]
913-588-3671
Andrea D. Jewell (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer CenterKansas CityKansas66160-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
University of Kansas Hospital-Indian Creek CampusOverland ParkKansas66211-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
Mayo Clinic in RochesterRochesterMinnesota55905
Site Public Contact
855-776-0015
Andrea E. Wahner Hendrickson (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Site Public Contact
336-713-6771
Janelle Darby (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
John L. Hays (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Site Public Contact
[email protected]
405-271-8777
Lauren E. Dockery (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Site Public Contact
[email protected]
215-600-9151
Mitchell I. Edelson (PRINCIPAL_INVESTIGATOR)
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Site Public Contact
800-811-8480
Alaina J. Brown (PRINCIPAL_INVESTIGATOR)
University of Virginia Cancer CenterCharlottesvilleVirginia22908
Site Public Contact
[email protected]
434-243-6303
Linda R. Duska (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic Hospital in Arizona· Phoenix, AZUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUM Sylvester Comprehensive Cancer Center at Coral Gables· Coral Gables, FL

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