Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02735980
Registration number
NCT02735980
Ethics application status
Date submitted
31/03/2016
Date registered
13/04/2016
Date last updated
17/03/2020
Titles & IDs
Public title
A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
Query!
Scientific title
A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
Query!
Secondary ID [1]
0
0
I4D-MC-JTJH
Query!
Secondary ID [2]
0
0
16015
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Prexasertib
Experimental: Prexasertib (Platinum Sensitive Disease) - 105 mg/m^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy).
Experimental: Prexasertib (Platinum Resistant Disease) - 105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).
Experimental: Prexasertib Exploratory Addendum (Platinum Sensitive Disease) - 40 mg/m^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease.
Treatment: Drugs: Prexasertib
Administered IV
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Query!
Assessment method [1]
0
0
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
Query!
Timepoint [1]
0
0
Baseline to 10 months
Query!
Secondary outcome [1]
0
0
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
Query!
Assessment method [1]
0
0
Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis.
Query!
Timepoint [1]
0
0
Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Query!
Secondary outcome [2]
0
0
Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)
Query!
Assessment method [2]
0
0
Pharmacokinetics(PK): Maximum Concentration of Prexasertib
Query!
Timepoint [2]
0
0
Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Query!
Secondary outcome [3]
0
0
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Query!
Assessment method [3]
0
0
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Query!
Timepoint [3]
0
0
Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Query!
Secondary outcome [4]
0
0
Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
Query!
Assessment method [4]
0
0
Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.
Query!
Timepoint [4]
0
0
Baseline through Disease Progression or Death from Any Cause to 28 months
Query!
Secondary outcome [5]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [5]
0
0
PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Query!
Timepoint [5]
0
0
Baseline to Disease Progression or Death (up to 9 months)
Query!
Secondary outcome [6]
0
0
Duration of Response (DoR)
Query!
Assessment method [6]
0
0
DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Query!
Timepoint [6]
0
0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months
Query!
Secondary outcome [7]
0
0
Overall Survival (OS)
Query!
Assessment method [7]
0
0
OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Query!
Timepoint [7]
0
0
Baseline up to 28 months
Query!
Secondary outcome [8]
0
0
Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)
Query!
Assessment method [8]
0
0
LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).
Query!
Timepoint [8]
0
0
Baseline up to 9 months
Query!
Secondary outcome [9]
0
0
Change From Baseline on the Average Symptom Burden Index (ASBI)
Query!
Assessment method [9]
0
0
ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).
Query!
Timepoint [9]
0
0
Baseline up to 9 months
Query!
Eligibility
Key inclusion criteria
- Have ED-SCLC and have received a prior platinum-based regimen
- Participants in Cohort 1 and in the addendum must have had an objective response to
prior platinum-based therapy with subsequent progression =90 days after the last dose
of platinum
- Participants in Cohort 2 must have either not had an objective response to prior
platinum based therapy or had progression <90 days after the last dose of platinum
- Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Have received more than 2 prior therapies for ED-SCLC (including immunotherapy,
targeted therapies, or chemotherapy)
- Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic
participants with treated CNS metastases are eligible for this study if they are not
currently receiving corticosteroids to treat CNS metastases
- Have previously completed or withdrawn from this study or any other study
investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown
hypersensitivity to any of the components of the prexasertib formulation
- Have a serious cardiac condition
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/05/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
12/02/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
133
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Hampshire
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Tennessee
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Besancon Cedex
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Lille
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Montpellier
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Vantoux
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Halle
Query!
Country [15]
0
0
Greece
Query!
State/province [15]
0
0
Athens
Query!
Country [16]
0
0
Greece
Query!
State/province [16]
0
0
Heraklion
Query!
Country [17]
0
0
Greece
Query!
State/province [17]
0
0
Patras
Query!
Country [18]
0
0
Korea, Republic of
Query!
State/province [18]
0
0
Seoul
Query!
Country [19]
0
0
Netherlands
Query!
State/province [19]
0
0
Amsterdam
Query!
Country [20]
0
0
Netherlands
Query!
State/province [20]
0
0
Breda
Query!
Country [21]
0
0
Netherlands
Query!
State/province [21]
0
0
Zwolle
Query!
Country [22]
0
0
Spain
Query!
State/province [22]
0
0
Barcelona
Query!
Country [23]
0
0
Spain
Query!
State/province [23]
0
0
Madrid
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Zaragoza
Query!
Country [25]
0
0
Turkey
Query!
State/province [25]
0
0
Antalya
Query!
Country [26]
0
0
Turkey
Query!
State/province [26]
0
0
Edirne
Query!
Country [27]
0
0
Turkey
Query!
State/province [27]
0
0
Istanbul
Query!
Country [28]
0
0
Turkey
Query!
State/province [28]
0
0
Izmir
Query!
Country [29]
0
0
Turkey
Query!
State/province [29]
0
0
Kayseri
Query!
Country [30]
0
0
Ukraine
Query!
State/province [30]
0
0
Dnipropetrovsk
Query!
Country [31]
0
0
Ukraine
Query!
State/province [31]
0
0
Kharkiv
Query!
Country [32]
0
0
Ukraine
Query!
State/province [32]
0
0
Sumy
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
Headington
Query!
Country [34]
0
0
United Kingdom
Query!
State/province [34]
0
0
Leicester
Query!
Country [35]
0
0
United Kingdom
Query!
State/province [35]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02735980
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT02735980
Download to PDF