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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03414047




Registration number
NCT03414047
Ethics application status
Date submitted
12/01/2018
Date registered
29/01/2018
Date last updated
19/08/2022

Titles & IDs
Public title
A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Scientific title
A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Secondary ID [1] 0 0
I4D-MC-JTJN
Secondary ID [2] 0 0
16712
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Prexasertib

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.

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.

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.

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.


Treatment: Drugs: Prexasertib
Administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline through Disease Progression (Up to 6 months)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib
Assessment method [1] 0 0
Pharmacokinetics(PK): Maximum Plasma Concentration of Prexasertib. The same dose was administered to Cohort 1, 2, 3 and 4 and were combined for analysis.
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline through Disease Progression (up to 6 months)
Secondary outcome [3] 0 0
Duration of Response
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (up to 20 months)
Secondary outcome [4] 0 0
Percentage of Participants With at Least a 50% Reduction in CA-125 Levels From Baseline
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Baseline, 4 Weeks
Secondary outcome [5] 0 0
Progression-Free Survival
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Baseline to Disease Progression or Death from any Cause (Up to 22 months)
Secondary outcome [6] 0 0
Overall Survival
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Baseline to Date of Death from Any Cause (Up to 26 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/10/2020
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [4] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [5] 0 0
Mater Adult Hospital Brisbane - South Brisbane
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
Burnside War Memorial Hospital - Toorak Gardens
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Wentworthville
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [8] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Rhode Island
Country [10] 0 0
United States of America
State/province [10] 0 0
South Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussel
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Wilrijk
Country [16] 0 0
Israel
State/province [16] 0 0
Haifa
Country [17] 0 0
Israel
State/province [17] 0 0
Jerusalem
Country [18] 0 0
Israel
State/province [18] 0 0
Ramat Gan
Country [19] 0 0
Italy
State/province [19] 0 0
Lazio
Country [20] 0 0
Italy
State/province [20] 0 0
Milan
Country [21] 0 0
Italy
State/province [21] 0 0
Naples
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Korea
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
Cordoba
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Greater London
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Greater Manchester
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Middlesex
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Surrey
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Northampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03414047