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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02735980




Registration number
NCT02735980
Ethics application status
Date submitted
31/03/2016
Date registered
7/04/2016
Date last updated
6/07/2018

Titles & IDs
Public title
A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
Scientific title
A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
Secondary ID [1] 0 0
I4D-MC-JTJH
Secondary ID [2] 0 0
16015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

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

Experimental: Prexasertib (Platinum Sensitive Disease) - Intravenous (IV) prexasertib administered on day 1 of every 14 day cycle

Experimental: Prexasertib (Platinum Resistant Disease) - IV prexasertib administered on day 1 of every 14 day cycle


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)
Timepoint [1] 0 0
Baseline through Disease Progression or Death (estimated at up to 28 months)
Secondary outcome [1] 0 0
Pharmacokinetics: Maximum Concentration of Prexasertib
Timepoint [1] 0 0
Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles)
Secondary outcome [2] 0 0
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Timepoint [2] 0 0
Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles)
Secondary outcome [3] 0 0
Disease Control Rate: Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)
Timepoint [3] 0 0
Baseline through Disease Progression or Death from Any Cause (estimated at up to 28 months)
Secondary outcome [4] 0 0
Progression-Free Survival
Timepoint [4] 0 0
Baseline to Disease Progression or Death (estimated at up to 28 months)
Secondary outcome [5] 0 0
Duration of Response
Timepoint [5] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 28 months)
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Baseline to Date of Death from Any Cause (estimated at up to 28 months)
Secondary outcome [7] 0 0
Change From Baseline in Lung Cancer Symptom Scale Score
Timepoint [7] 0 0
Baseline, Short Term Follow-Up (estimated at up to 28 months)
Secondary outcome [8] 0 0
Change from Baseline on the Average Symptom Burden Index (ASBI)
Timepoint [8] 0 0
Baseline, Short Term Follow-Up (estimated at up to 28 months)

Eligibility
Key inclusion criteria
- Have ED-SCLC and have received a prior platinum-based regimen

- Participants in Cohort 1 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bedford Park
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Concord
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Herston
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Melbourne
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Randwick
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - South Brisbane
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wentworthville
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
2145 - Wentworthville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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Connecticut
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United States of America
State/province [3] 0 0
District of Columbia
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
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New Hampshire
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
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
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Belgium
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Brussel
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Belgium
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Leuven
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Belgium
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Wilrijk
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France
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Besancon Cedex
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France
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Lille
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France
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Montpellier
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France
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Vantoux
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Germany
State/province [18] 0 0
Halle
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Patras
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Italy
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Milano
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Italy
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Napoli
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Italy
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Roma
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Zwolle
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Barcelona
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Córdoba
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Madrid
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Spain
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Málaga
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Spain
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Zaragoza
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Turkey
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Antalya
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Sumy
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United Kingdom
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Glasgow
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United Kingdom
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Guildford
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United Kingdom
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Headington
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Northampton
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United Kingdom
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Sheffield

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02735980
Trial related presentations / publications
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable