A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring DNA damage repair, replication stress
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Arizona Oncology Associates, P.C.
- Kaiser Permanente Medical Center
- University of Southern Florida School of Medicine
- Dana Farber Cancer Institute
- Research Medical Center
- Dartmouth Hitchcock Medical Center
- Cancer Care Associates
- Thomas Jefferson University
- Rhode Island Hospital
- Sioux Valley Clinic
- University of Tennessee Medical Center
- Sarah Cannon Research Institute SCRI
- Tennessee Oncology PLLC
- Seattle Cancer Care Alliance
- Concord Repatriation General Hospital
- Prince of Wales Hospital
- Westmead Hospital
- Royal Brisbane and Womens Hospital
- Mater Adult Hospital Brisbane
- Flinders Medical Centre
- Burnside War Memorial Hospital
- Peter MacCallum Cancer Centre
- Institut Jules Bordet
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
- GZA St Augustinus
- Rambam Medical Center
- Shaare Zedek Medical Center
- Sheba Medical Center
- Policlinico Univ. Agostino Gemelli
- Istituto Europeo di Oncologia
- Istituto Tumori Fondazione G. Pascale IRCCS
- Samsung Medical Center
- Seoul National University Hospital
- Asan Medical Center
- Severance Hospital Yonsei University Health System
- Hospital Universitari Vall d'Hebron
- Hospital Reina Sofia
- Hospital Universitario Ramon y Cajal
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- University College Hospital - London
- Christie NHS Foundation Trust
- Mount Vernon Hospital
- Royal Surrey County Hospital
- Royal Marsden Hospital
- Northampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Prexasertib Cohort 1
Prexasertib Cohort 2
Prexasertib Cohort 3
Prexasertib Cohort 4
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.
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.
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.
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.