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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03414047
Recruitment Status : Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Prexasertib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : June 3, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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
Administered IV
Other Name: LY2606368

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
Other Name: LY2606368

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
Other Name: LY2606368

Experimental: Prexasertib Cohort 4
Participants with platinum refractory disease.
Drug: Prexasertib
Administered IV
Other Name: LY2606368




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414047


  Show 46 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03414047     History of Changes
Other Study ID Numbers: 16712
I4D-MC-JTJN ( Other Identifier: Eli Lilly and Company )
2017-004009-42 ( EudraCT Number )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
DNA damage repair
replication stress

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type