A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 172
- Locations
- 46
- Primary Endpoint
- Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Prexasertib (Drug)
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.
Intervention: Prexasertib (Drug)
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.
Intervention: Prexasertib (Drug)
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.
Intervention: Prexasertib (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Time Frame: Baseline through Disease Progression (Up to 6 months)
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.
Secondary Outcomes
- 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))
- Overall Survival(Baseline to Date of Death from Any Cause (Up to 26 months))