Clinical Trials /

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

NCT03414047

Description:

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

Related Conditions:
  • Fallopian Tube Carcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
  • Official Title: A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

Clinical Trial IDs

  • ORG STUDY ID: 16712
  • SECONDARY ID: I4D-MC-JTJN
  • SECONDARY ID: 2017-004009-42
  • NCT ID: NCT03414047

Conditions

  • Ovarian Cancer

Interventions

DrugSynonymsArms
PrexasertibLY2606368Prexasertib Cohort 1

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Prexasertib Cohort 1ExperimentalParticipants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
  • Prexasertib
Prexasertib Cohort 2ExperimentalParticipants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.
  • Prexasertib
Prexasertib Cohort 3ExperimentalParticipants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
  • Prexasertib
Prexasertib Cohort 4ExperimentalParticipants with platinum refractory disease.
  • Prexasertib

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:Percentage of participants who achieve CR or PR: ORR

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6
Measure: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)
Safety Issue:
Description:DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months
Measure: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)
Safety Issue:
Description:Duration of response
Measure:Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline
Time Frame:Baseline, 4 Weeks
Safety Issue:
Description:Percentage of participants with at least a 50% reduction in CA-125 levels from baseline
Measure:Progression-Free Survival
Time Frame:Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)
Safety Issue:
Description:Progression-free survival
Measure:Overall Survival
Time Frame:Baseline to Date of Death from Any Cause (estimated at up to 24 months)
Safety Issue:
Description:Overall survival

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • DNA damage repair
  • replication stress

Last Updated

February 2, 2018