Status:
COMPLETED
A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2020
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT03414047
Start Date
April 10 2018
End Date
October 3 2020
Last Update
August 19 2022
Active Locations (46)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Oncology Associates, P.C.
Tucson, Arizona, United States, 85711
2
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
3
University of Southern Florida School of Medicine
Gainesville, Florida, United States, 32610-0296
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215