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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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:
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) - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Timepoint [1] 0 0
Baseline to 10 months
Secondary outcome [1] 0 0
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
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
Secondary outcome [2] 0 0
Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)
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
Secondary outcome [3] 0 0
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
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
Secondary outcome [4] 0 0
Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
Timepoint [4] 0 0
Baseline through Disease Progression or Death from Any Cause to 28 months
Secondary outcome [5] 0 0
Progression-Free Survival (PFS)
Timepoint [5] 0 0
Baseline to Disease Progression or Death (up to 9 months)
Secondary outcome [6] 0 0
Duration of Response (DoR)
Timepoint [6] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Baseline up to 28 months
Secondary outcome [8] 0 0
Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)
Timepoint [8] 0 0
Baseline up to 9 months
Secondary outcome [9] 0 0
Change From Baseline on the Average Symptom Burden Index (ASBI)
Timepoint [9] 0 0
Baseline up to 9 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/02/2019
Sample size
Target
Accrual to date
Final
133
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
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
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
France
State/province [10] 0 0
Besancon Cedex
Country [11] 0 0
France
State/province [11] 0 0
Lille
Country [12] 0 0
France
State/province [12] 0 0
Montpellier
Country [13] 0 0
France
State/province [13] 0 0
Vantoux
Country [14] 0 0
Germany
State/province [14] 0 0
Halle
Country [15] 0 0
Greece
State/province [15] 0 0
Athens
Country [16] 0 0
Greece
State/province [16] 0 0
Heraklion
Country [17] 0 0
Greece
State/province [17] 0 0
Patras
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Netherlands
State/province [19] 0 0
Amsterdam
Country [20] 0 0
Netherlands
State/province [20] 0 0
Breda
Country [21] 0 0
Netherlands
State/province [21] 0 0
Zwolle
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Spain
State/province [24] 0 0
Zaragoza
Country [25] 0 0
Turkey
State/province [25] 0 0
Antalya
Country [26] 0 0
Turkey
State/province [26] 0 0
Edirne
Country [27] 0 0
Turkey
State/province [27] 0 0
Istanbul
Country [28] 0 0
Turkey
State/province [28] 0 0
Izmir
Country [29] 0 0
Turkey
State/province [29] 0 0
Kayseri
Country [30] 0 0
Ukraine
State/province [30] 0 0
Dnipropetrovsk
Country [31] 0 0
Ukraine
State/province [31] 0 0
Kharkiv
Country [32] 0 0
Ukraine
State/province [32] 0 0
Sumy
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Headington
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Leicester
Country [35] 0 0
United Kingdom
State/province [35] 0 0
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/study/NCT02735980
Trial related presentations / publications
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

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02735980