ClinicalTrials.gg
CompletedNCT03414047Updated Aug 19, 2022Results posted

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

A Phase 2 interventional study of Prexasertib in Ovarian Cancer, sponsored by Eli Lilly and Company. Completed at 46 sites in 8 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-19.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
172
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 29 studies in Ovarian Neoplasms by Eli Lilly and Company — 6 open to participants now, 9 under way, 1 of them phase 3. Ovarian Neoplasms · Eli Lilly and Company.

Enrollment
12th of 26
172 · median 158
Started
2018
the only one that year
Phase 2
14 of 29
none open now
Registered
19th of 29
by date

Among the 29 studies in Ovarian Neoplasms by Eli Lilly and Company, this one is the 12th largest by enrollment of the 26 interventional ones that give a count, is the only one that started in 2018, is one of 14 in phase 2, and was the 19th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

6 of the 29 studies in Ovarian Neoplasms by Eli Lilly and Company are open now, in 12 countries. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 6 open studies →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

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Get alerts for this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 29 studies in Ovarian Neoplasms by Eli Lilly and Company, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Ovarian Cancer

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Keywords

  • DNA damage repair
  • replication stress
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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 disease.
  • Have adequate organ function.
  • Must be able and willing to undergo mandatory tumor .

Exclusion criteria

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 or .
  • Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have to the study drug or .
  • 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 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 , 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
172 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Prexasertib

  • Experimental
    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.

    Drug: Prexasertib

  • Experimental
    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.

    Drug: Prexasertib

  • Experimental
    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.

    Drug: Prexasertib

Interventions

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline through Disease Progression (Up to 6 months)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Results

Posted Jun 17, 2020

Participant flow

Completers included participants who died from any cause and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.

Participant flow — Overall Study
MilestonePrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
Started53464129
Received at least one dose of study drug53464129
Completed51463827
Not completed2032
Withdrew: Adverse event0011
Withdrew: Physician decision1001
Withdrew: Withdrawal by subject1020

Outcome measures

PrimaryPercentage 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.

Time frame:
Baseline through Disease Progression (Up to 6 months)
Reported as:
Number · Percentage of Participants
Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Percentage of ParticipantsPrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)11.3 (4.3 to 23.0)13.0 (4.9 to 26.3)12.2 (4.1 to 26.2)6.9 (0.8 to 22.8)
SecondaryPharmacokinetics (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.

Time frame:
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)
Reported as:
Geometric mean · nanograms per milliliter(ng/mL)
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib
nanograms per milliliter(ng/mL)Prexasertib
Cycle 1668 ± 50
Cycle 2718 ± 62
Cycle 4678 ± 61
Cycle 6672 ± 42
SecondaryDisease 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.

Time frame:
Baseline through Disease Progression (up to 6 months)
Reported as:
Number · Percentage of participants
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months
Percentage of participantsPrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months45.3 (31.6 to 59.6)32.6 (19.5 to 48.0)31.7 (18.1 to 48.1)31.0 (15.3 to 50.8)
SecondaryDuration 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.

Time frame:
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (up to 20 months)
Reported as:
Median · Months
Duration of Response
MonthsPrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
Duration of Response8.57 (5.55 to NA)3.84 (2.79 to NA)5.55 (3.65 to 9.36)5.31 (5.06 to NA)
SecondaryPercentage 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.

Time frame:
Baseline, 4 Weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least a 50% Reduction in CA-125 Levels From Baseline
Percentage of participantsPrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
Percentage of Participants With at Least a 50% Reduction in CA-125 Levels From Baseline39.634.817.137.9
SecondaryProgression-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.

Time frame:
Baseline to Disease Progression or Death from any Cause (Up to 22 months)
Reported as:
Median · Months
Progression-Free Survival
MonthsPrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
Progression-Free Survival3.91 (3.68 to 5.68)3.71 (3.12 to 4.70)3.58 (1.87 to 3.91)3.71 (1.77 to 4.70)
SecondaryOverall 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.

Time frame:
Baseline to Date of Death from Any Cause (Up to 26 months)
Reported as:
Median · Months
Overall Survival
MonthsPrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
Overall Survival13.04 (7.46 to 19.25)14.32 (11.76 to 16.46)11.14 (7.23 to 16.43)8.18 (6.18 to 11.93)

Adverse events

Collected over Baseline, upto 26 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Prexasertib Cohort 12/53 (3.8%)23/53 (43.4%)53/53 (100%)
Prexasertib Cohort 21/46 (2.2%)17/46 (37%)44/46 (95.7%)
Prexasertib Cohort 31/41 (2.4%)19/41 (46.3%)39/41 (95.1%)
Prexasertib Cohort 41/29 (3.4%)15/29 (51.7%)28/29 (96.6%)
Most frequent serious events
Showing 10 of 74
Most frequent serious events
EventPrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
Febrile neutropeniaBlood and lymphatic system disorders5/533/465/414/29
PyrexiaGeneral disorders1/535/461/411/29
VomitingGastrointestinal disorders1/534/461/413/29
NeutropeniaBlood and lymphatic system disorders4/533/464/412/29
AnaemiaBlood and lymphatic system disorders0/532/462/412/29
Abdominal painGastrointestinal disorders0/531/461/412/29
Small intestinal obstructionGastrointestinal disorders1/533/461/412/29
PneumoniaInfections and infestations1/531/462/412/29
SepsisInfections and infestations2/531/460/412/29
Urinary tract infectionInfections and infestations1/533/460/411/29
Most frequent other events
Showing 10 of 71
Most frequent other events
EventPrexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4
NauseaGastrointestinal disorders19/5324/4615/4116/29
VomitingGastrointestinal disorders21/5313/4611/4114/29
AnaemiaBlood and lymphatic system disorders20/5317/4615/4112/29
FatigueGeneral disorders21/5319/4612/4112/29
Abdominal painGastrointestinal disorders14/5318/4611/4110/29
NeutropeniaBlood and lymphatic system disorders19/5310/4611/4110/29
DiarrhoeaGastrointestinal disorders19/5315/467/418/29
ThrombocytopeniaBlood and lymphatic system disorders17/5314/4614/417/29
PyrexiaGeneral disorders13/535/467/418/29
ConstipationGastrointestinal disorders13/5312/468/415/29

Baseline characteristics

All randomized participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(Years)Prexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4Total
Mean61.3 ± 9.462.3 ± 9.459.5 ± 8.659.0 ± 13.460.8 ± 10.0
Sex: Female, Male
Sex: Female, Male(Participants)Prexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4Total
Female53464129169
Male00000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Prexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4Total
Hispanic or Latino13004
Not Hispanic or Latino48403928155
Unknown or Not Reported432110
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Prexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4Total
American Indian or Alaska Native00000
Asian684321
Native Hawaiian or Other Pacific Islander11002
Black or African American01012
White46363725144
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)Prexasertib Cohort 1Prexasertib Cohort 2Prexasertib Cohort 3Prexasertib Cohort 4Total
South Korea452213
Belgium41308
United States61331032
United Kingdom694120
Italy448723
Israel637420
Australia14710334
Spain944219
08

Study locations

46 sites
  • Arizona Oncology Associates, P.C.
    Tucson, Arizona 85711, United States
  • Kaiser Permanente Medical Center
    Vallejo, California 94589, United States
  • University of Southern Florida School of Medicine
    Gainesville, Florida 32610-0296, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Research Medical Center
    Kansas City, Missouri 63142, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756-0001, United States
  • Cancer Care Associates
    Tulsa, Oklahoma 74146, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Sioux Valley Clinic
    Sioux Falls, South Dakota 57104, United States
  • University of Tennessee Medical Center
    Knoxville, Tennessee 37920, United States
  • Sarah Cannon Research Institute SCRI
    Nashville, Tennessee 37203, United States
  • Tennessee Oncology PLLC
    Nashville, Tennessee 37203, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • Concord Repatriation General Hospital
    Concord, New South Wales 2139, Australia
  • Prince of Wales Hospital
    Randwick, New South Wales 2031, Australia
  • Westmead Hospital
    Wentworthville, New South Wales 2145, Australia
  • Royal Brisbane and Womens Hospital
    Herston, Queensland 4029, Australia
  • Mater Adult Hospital Brisbane
    South Brisbane, Queensland 4101, Australia
  • Flinders Medical Centre
    Bedford Park, South Australia 5042, Australia
  • Burnside War Memorial Hospital
    Toorak Gardens, South Australia 5065, Australia
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3000, Australia
  • Institut Jules Bordet
    Brussel, 1000, Belgium
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    Leuven, 3000, Belgium
  • GZA St Augustinus
    Wilrijk, 2610, Belgium
  • Rambam Medical Center
    Haifa, 3109601, Israel
  • Shaare Zedek Medical Center
    Jerusalem, 9103102, Israel
  • Sheba Medical Center
    Ramat Gan, 5265601, Israel
  • Policlinico Univ. Agostino Gemelli
    Roma, Lazio 00168, Italy
  • Istituto Europeo di Oncologia
    Milano, Milan 20141, Italy
  • Istituto Tumori Fondazione G. Pascale IRCCS
    Napoli, Naples 80131, Italy
  • Samsung Medical Center
    Seoul, Korea 06351, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Severance Hospital Yonsei University Health System
    Seoul, 120-792, Korea, Republic of
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Reina Sofia
    Cordoba, 14004, Spain
  • Hospital Universitario Ramon y Cajal
    Madrid, 28034, Spain
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
  • University College Hospital - London
    London, Greater London NW1 2BU, United Kingdom
  • Christie NHS Foundation Trust
    Manchester, Greater Manchester M20 4BX, United Kingdom
  • Mount Vernon Hospital
    Northwood, Middlesex HA6 2RN, United Kingdom
  • Royal Surrey County Hospital
    Guildford, Surrey GU2 7XX, United Kingdom
  • Royal Marsden Hospital
    Sutton, Surrey SM2 5PT, United Kingdom
  • Northampton General Hospital
    Northampton, NN1 5BD, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Data sharing details ↗ · vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Jun 2019, 13 months.

Results were first posted in Jun 2020, 1 year after primary completion.

Of 116 industry-sponsored phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 51. This study's 13 months is below that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2018
First posted
Jan 29, 2018
StartActual
Apr 10, 2018
Primary completionActual
Jun 3, 2019
CompletionActual
Oct 3, 2020
Results first posted
Jun 17, 2020
Last update
Aug 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03414047
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Apr 10, 2018
Primary completion
Jun 3, 2019
Completion
Oct 3, 2020
Results posted
Jun 17, 2020
Last update
Aug 19, 2022

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Prexasertib

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