A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
3 other identifiers
interventional
172
8 countries
46
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Apr 2018
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedStudy Start
First participant enrolled
April 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2019
CompletedResults Posted
Study results publicly available
June 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2020
CompletedAugust 19, 2022
August 1, 2022
1.1 years
January 12, 2018
May 29, 2020
August 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100.
Baseline through Disease Progression (Up to 6 months)
Secondary Outcomes (6)
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib
Cycle 1, Cycle 2, Cycle 4, Cycle 6 (Day 1 (End of prexasertib infusion (+15 min), 1-2 hours following end of prexasertib infusion), Cycle 2, day 1(Prior to start of prexasertib infusion)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months
Baseline through Disease Progression (up to 6 months)
Duration of Response
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (up to 20 months)
Percentage of Participants With at Least a 50% Reduction in CA-125 Levels From Baseline
Baseline, 4 Weeks
Progression-Free Survival
Baseline to Disease Progression or Death from any Cause (Up to 22 months)
- +1 more secondary outcomes
Study Arms (4)
Prexasertib Cohort 1
EXPERIMENTALParticipants 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 Cohort 2
EXPERIMENTALParticipants 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 Cohort 3
EXPERIMENTALParticipants 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 Cohort 4
EXPERIMENTALParticipants 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.
Interventions
Administered IV
Eligibility Criteria
You may qualify if:
- Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.
- 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.
You may not qualify if:
- Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Arizona Oncology Associates, P.C.
Tucson, Arizona, 85711, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
University of Southern Florida School of Medicine
Gainesville, Florida, 32610-0296, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Research Medical Center
Kansas City, Missouri, 63142, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
Cancer Care Associates
Tulsa, Oklahoma, 74146, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Sioux Valley Clinic
Sioux Falls, South Dakota, 57104, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Wentworthville, New South Wales, 2145, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029, Australia
Mater Adult Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Burnside War Memorial Hospital
Toorak Gardens, South Australia, 5065, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Institut Jules Bordet
Brussels, 1000, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
GZA St Augustinus
Wilrijk, 2610, Belgium
Rambam Medical Center
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Policlinico Univ. Agostino Gemelli
Rome, Lazio, 00168, Italy
Istituto Europeo di Oncologia
Milan, Milan, 20141, Italy
Istituto Tumori Fondazione G. Pascale IRCCS
Napoli, Naples, 80131, Italy
Samsung Medical Center
Seoul, Korea, 06351, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Severance Hospital Yonsei University Health System
Seoul, 120-792, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
University College Hospital - London
London, Greater London, NW1 2BU, United Kingdom
Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX, United Kingdom
Mount Vernon Hospital
Northwood, Middlesex, HA6 2RN, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Northampton General Hospital
Northampton, NN1 5BD, United Kingdom
Related Publications (1)
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.
PMID: 36192237DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2018
First Posted
January 29, 2018
Study Start
April 10, 2018
Primary Completion
June 3, 2019
Study Completion
October 3, 2020
Last Updated
August 19, 2022
Results First Posted
June 17, 2020
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.