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Ovarian CancerPhase 2NCT03414047

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

A Phase 2 study testing Prexasertib in people with Ovarian Cancer, run by Eli Lilly and Company at 46 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Prexasertib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
46 sitesin 8 countries
Study dates
10 Apr 2018to 3 Oct 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

46 sites in 8 countries.

46 sites in 8 countries

United States14 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Southern Florida School of Medicine

    Gainesville, Florida, 32610-0296

  • Research Medical Center

    Kansas City, Missouri, 63142

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0001

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Sioux Valley Clinic

    Sioux Falls, South Dakota, 57104

  • Arizona Oncology Associates, P.C.

    Tucson, Arizona, 85711

  • Cancer Care Associates

    Tulsa, Oklahoma, 74146

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

Other trials in United States

Australia8 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Royal Brisbane and Womens Hospital

    Herston, Queensland, 4029

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Mater Adult Hospital Brisbane

    South Brisbane, Queensland, 4101

  • Burnside War Memorial Hospital

    Toorak Gardens, South Australia, 5065

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

Other trials in Australia

United Kingdom6 sites

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • University College Hospital - London

    London, Greater London, NW1 2BU

  • Christie NHS Foundation Trust

    Manchester, Greater Manchester, M20 4BX

  • Northampton General Hospital

    Northampton, NN1 5BD

  • Mount Vernon Hospital

    Northwood, Middlesex, HA6 2RN

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

South Korea4 sites

  • Samsung Medical Center

    Seoul, Korea, 06351

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Severance Hospital Yonsei University Health System

    Seoul, 120-792

Other trials in South Korea

Belgium3 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • GZA St Augustinus

    Wilrijk, 2610

Other trials in Belgium

Israel3 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Italy3 sites

  • Istituto Europeo di Oncologia

    Milan, Milan, 20141

  • Istituto Tumori Fondazione G. Pascale IRCCS

    Naples, Naples, 80131

  • Policlinico Univ. Agostino Gemelli

    Rome, Lazio, 00168

Other trials in Italy

About this study

Official title: A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

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

Conditions
Ovarian Cancer
Being tested
Prexasertib
Keywords
DNA damage repair, replication stress
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrexasertibDrug

    Also called LY2606368

    Administered IV

Study groups in NCT03414047
Study groupRoleWhat they receive
Prexasertib Cohort 1ExperimentalParticipants 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.
Receives: Drug: Prexasertib
Prexasertib Cohort 2ExperimentalParticipants 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.
Receives: Drug: Prexasertib
Prexasertib Cohort 3ExperimentalParticipants 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.
Receives: Drug: Prexasertib
Prexasertib Cohort 4ExperimentalParticipants 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.
Receives: Drug: Prexasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)

    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.

    Measured: Baseline through Disease Progression (Up to 6 months)

Secondary outcomes (6)

  1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib

    Pharmacokinetics(PK): Maximum Plasma Concentration of Prexasertib. The same dose was administered to Cohort 1, 2, 3 and 4 and were combined for analysis.

    Measured: 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)

  2. Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months

    DCR is defined as the number of participants who achieve a best overall response of CR, PR or SD for ≥4 months as determined by per RECIST version 1.1. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.

    Measured: Baseline through Disease Progression (up to 6 months)

  3. Duration of Response

    Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.

    Measured: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (up to 20 months)

  4. Percentage of Participants With at Least a 50% Reduction in CA-125 Levels From Baseline

    CA-125 response is defined as ≥50% reduction in CA-125 levels from a pretreatment sample. The response must be confirmed and maintained for ≥28 days according to GCIG criteria. Participants must have a pretreatment sample that is ≥2 times the upper limit of the reference range and obtained within 2 weeks before starting the treatment.

    Measured: Baseline, 4 Weeks

  5. Progression-Free Survival

    Progression-Free Survival (PFS) is defined as the time from the date of enrollment until the first occurrence of documented disease progression per RECIST 1.1, or death from any cause in the absence of progressive disease (PD). Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.

    Measured: Baseline to Disease Progression or Death from any Cause (Up to 22 months)

  6. Overall Survival

    Overall survival (OS) is defined as the time from the date of enrollment until death from any cause. If the participant is alive, lost to follow-up or withdrawn from study at the time of data analysis, OS data will be censored on the last date the participant is known to be alive.

    Measured: Baseline to Date of Death from Any Cause (Up to 26 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2018
  2. Study start10 Apr 2018
  3. Primary completion3 Jun 2019
  4. Study completion3 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03414047
Sponsor's protocol ID
16712
Other IDs
I4D-MC-JTJN, 2017-004009-42, 2017
Status last verified
Aug 2022
First submitted
12 Jan 2018
Last updated
19 Aug 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Konstantinopoulos PA, Lee JM, Gao B, Miller R, Lee JY, Colombo N, Vergote I, Credille KM, Young SR, McNeely S, Wang XA, Lin AB, Shapira-Frommer R. A Phase 2 study of prexasertib (LY2606368) in platinum resistant or refractory recurrent ovarian cancer. Gynecol Oncol. 2022 Nov;167(2):213-225. doi: 10.1016/j.ygyno.2022.09.019. Epub 2022 Sep 30.

    PubMed 36192237

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prexasertib in people with Ovarian Cancer, run by Eli Lilly and Company at 46 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Australia, United Kingdom, Spain, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03414047, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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