A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

Completed · Phase 2

Conditions studied: Ovarian Cancer

In brief

The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.

Key facts

Study ID

NCT03414047

Run by

Eli Lilly and Company

People needed

172

Starts

2018-04-10

Expected to finish

2020-10-03

Last updated by the study team

2022-08-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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