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

ID: NCT03414047
Status: Not yet recruiting
Phase: Phase 2
Start Date: April 12, 2018
First Submitted: January 12, 2018
Last Updated: February 23, 2018
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company
Location: Australia, Belgium, Israel, Italy, Korea, Republic of, Spain, United Kingdom, United States
Conditions: Ovarian Cancer
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Ovarian Cancer

Drug: Prexasertib
Other Names
LY2606368
Phase 2

Tracking Information

First Submitted DateJanuary 12, 2018
Last Update Posted DateFebruary 23, 2018
Anticipated Start DateApril 12, 2018
Anticipated Completion DateApril 16, 2019
Anticipated Primary Completion DateApril 16, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) [Time Frame: Baseline through Disease Progression (estimated at up to 12 months)]

    Percentage of participants who achieve CR or PR: ORR

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib [Time Frame: Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)]

    PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6

  • Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months [Time Frame: Baseline through Disease Progression (estimated at up to 12 months)]

    DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months

  • Duration of Response [Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)]

    Duration of response

  • Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline [Time Frame: Baseline, 4 Weeks]

    Percentage of participants with at least a 50% reduction in CA-125 levels from baseline

  • Progression-Free Survival [Time Frame: Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)]

    Progression-free survival

  • Overall Survival [Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 24 months)]

    Overall survival

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Official TitleA Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
180
Allocation
Non-Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Ovarian Cancer
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Prexasertib

Administered IV

Other Names
LY2606368
Study Groups/Cohorts
Prexasertib Cohort 1
Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.

Prexasertib Cohort 2
Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.

Prexasertib Cohort 3
Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.

Prexasertib Cohort 4
Participants with platinum refractory disease.

Study Arms
Experimental Prexasertib Cohort 1
Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
Drug : Prexasertib
Administered IV

Experimental Prexasertib Cohort 2
Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.
Drug : Prexasertib
Administered IV

Experimental Prexasertib Cohort 3
Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
Drug : Prexasertib
Administered IV

Experimental Prexasertib Cohort 4
Participants with platinum refractory disease.
Drug : Prexasertib
Administered IV

Arm Intervention/Treatment
Experimental Prexasertib Cohort 1
Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
Drug : Prexasertib
Experimental Prexasertib Cohort 2
Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.
Drug : Prexasertib
Experimental Prexasertib Cohort 3
Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
Drug : Prexasertib
Experimental Prexasertib Cohort 4
Participants with platinum refractory disease.
Drug : Prexasertib

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment180
Completion DateApril 16, 2019
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 steroids.
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Australia
Belgium
Israel
Italy
Korea, Republic of
Spain
United Kingdom
United States

Administrative Information

NCT Number:NCT03414047
Other Study ID Numbers
16712
I4D-MC-JTJN
2017-004009-42
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Eli Lilly and Company
Collaborators
Not Available
Investigators
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