A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
NCT ID: NCT03414047
Last Updated: 2022-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2018-04-10
2020-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prexasertib Cohort 1
Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
Prexasertib
Administered IV
Prexasertib Cohort 2
Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received \<3 lines of prior therapy.
Prexasertib
Administered IV
Prexasertib Cohort 3
Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
Prexasertib
Administered IV
Prexasertib Cohort 4
Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
Prexasertib
Administered IV
Interventions
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Prexasertib
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.
* Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.
* Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.
* Cohort 3: Are BRCA positive and have previously received a PARP.
* Cohort 4: Have primary platinum refractory disease.
* Have adequate organ function.
* Must be able and willing to undergo mandatory tumor biopsy.
Exclusion Criteria
* Have known central nervous system malignancy or metastasis.
* Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.
* Have at least one of the following:
* history of abdominal fistula or gastrointestinal perforation
* intra-abdominal abscess within last 3 months prior to the first dose of study drug
* a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug
* Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).
* Have a serious cardiac condition.
* Have a history of prior radiotherapy to the whole pelvis.
* Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.
* Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Arizona Oncology Associates, P.C.
Tucson, Arizona, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
University of Southern Florida School of Medicine
Gainesville, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Research Medical Center
Kansas City, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Sioux Valley Clinic
Sioux Falls, South Dakota, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Mater Adult Hospital Brisbane
South Brisbane, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Burnside War Memorial Hospital
Toorak Gardens, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Institut Jules Bordet
Brussels, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
GZA St Augustinus
Wilrijk, , Belgium
Rambam Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Policlinico Univ. Agostino Gemelli
Rome, Lazio, Italy
Istituto Europeo di Oncologia
Milan, Milan, Italy
Istituto Tumori Fondazione G. Pascale IRCCS
Napoli, Naples, Italy
Samsung Medical Center
Seoul, Korea, South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
University College Hospital - London
London, Greater London, United Kingdom
Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Mount Vernon Hospital
Northwood, Middlesex, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Countries
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References
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Konstantinopoulos PA, Lee JM, Gao B, Miller R, Lee JY, Colombo N, Vergote I, Credille KM, Young SR, McNeely S, Wang XA, Lin AB, Shapira-Frommer R. A Phase 2 study of prexasertib (LY2606368) in platinum resistant or refractory recurrent ovarian cancer. Gynecol Oncol. 2022 Nov;167(2):213-225. doi: 10.1016/j.ygyno.2022.09.019. Epub 2022 Sep 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Other Identifiers
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I4D-MC-JTJN
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004009-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16712
Identifier Type: -
Identifier Source: org_study_id
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