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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02450539




Registration number
NCT02450539
Ethics application status
Date submitted
19/05/2015
Date registered
21/05/2015

Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
Scientific title
A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
Secondary ID [1] 0 0
I3Y-MC-JPBX
Secondary ID [2] 0 0
15806
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer Stage IV 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Docetaxel

Experimental: Abemaciclib - 200 milligram (mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Active comparator: Docetaxel - 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.


Treatment: Drugs: Abemaciclib
Administered orally

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

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Assessment method [1] 0 0
PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.
Timepoint [1] 0 0
Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Clearance of Abemaciclib
Assessment method [1] 0 0
Pharmacokinetics (PK): Clearance of Abemaciclib
Timepoint [1] 0 0
Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
Secondary outcome [2] 0 0
PK: Volume of Distribution of Abemaciclib
Assessment method [2] 0 0
PK: Volume of Distribution of Abemaciclib
Timepoint [2] 0 0
Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
Secondary outcome [3] 0 0
Overall Survival (OS)
Assessment method [3] 0 0
OS was defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as the data inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Timepoint [3] 0 0
Baseline to Date of Death from Any Cause (Up To 28 Months)
Secondary outcome [4] 0 0
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Assessment method [4] 0 0
Overall response was defined as the percentage of randomized participants achieving a best overall response (BoR) of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is 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.
Timepoint [4] 0 0
Baseline to Objective Progression (Up To 6 Months)
Secondary outcome [5] 0 0
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)
Assessment method [5] 0 0
DCR is the percentage of randomized participants who achieved a complete response, partial response or stable disease using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Complete response (CR) is defined as the disappearance of all target and non-target lesions, and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of 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. Stable disease was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Timepoint [5] 0 0
Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)
Secondary outcome [6] 0 0
Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2
Assessment method [6] 0 0
Worsening of ECOG performance status is the duration from randomization to ECOG PFS of \>/=2. Participants without an ECOG PFS \>/=2 are censored at last adequate post baseline ECOG Performance Status or randomization date (whichever is last). The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5 - Dead
Timepoint [6] 0 0
Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)
Secondary outcome [7] 0 0
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores
Assessment method [7] 0 0
MDASI-LC included 33 items:6 interference and 27 symptom(3 lung-cancer (LC),8 brain tumor (BT),and 3 study-specific(headache,diarrhea, and rash).Analyzed endpoints were 9 constructs:3 single-items (headache,diarrhea,and rash) and 6 composites(interference+core,LC,core+LC,BT, and core+LC worst 5 baseline).Data for all 9 constructs were collected by an 11-point numeric rating scale anchored at 0(not present or does not interfere) and 10(as bad as you can imagine or interfered completely).The measurement range was 10 (maximum score-minimum score). Between-group difference in regression-predicted change from baseline were estimated for each specified construct. MMRM models included independent variables treatment,visit, treatment\*visit,and baseline score. Group-level negative change from baseline indicated group improvement.
Timepoint [7] 0 0
Baseline through End of Study (Up To 6 Months)
Secondary outcome [8] 0 0
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score
Assessment method [8] 0 0
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Overall self-rated health was measured with a vertical 20 cm visual analog scale (VAS) anchored at 0 (worst health) and ranged through 100 (best health). Between-group differences in regression-predicted change from baseline score were estimated for VAS scores. MMRM models included independent variables treatment, visit, treatment\*visit, and baseline score. Group-level negative change from baseline indicated group improvement.
Timepoint [8] 0 0
Baseline to Measured Progressive Disease (Up To 6 Months)
Secondary outcome [9] 0 0
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value
Assessment method [9] 0 0
There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to.The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using UK weights,health dimensions(mobility,self-care,usual activities,pain/discomfort, and anxiety/depression) into a single index value;the dimensions are not separately scored.The index is marked missing when =1 dimensions are missing.The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death.The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index .MMRM models included independent variables treatment, visit, treatment\*visit, and baseline score.Group-level negative change from baseline indicated group improvement.
Timepoint [9] 0 0
Baseline to Measured Progressive Disease (Up To 6 Months)

Eligibility
Key inclusion criteria
* Confirmed diagnosis of stage IV NSCLC.
* Have progressed during or after platinum-based chemotherapy for advanced disease.
* Have not received prior treatment with docetaxel.
* Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material.
* Have adequate organ function including hematology, renal, and liver.
* Have good performance score (0-1).
* Have measurable disease per RECIST 1.1.
* Agree to use a reliable medically approved method of birth control.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment administered is not known.
* Are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
* Have the presence of unstable central nervous system (CNS) metastasis.
* Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
6/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/07/2020
Sample size
Target
Accrual to date
Final
159
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. - Camperdown
Recruitment hospital [2] 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. - Randwick
Recruitment hospital [3] 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. - South Brisbane
Recruitment hospital [4] 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. - Wollongong
Recruitment hospital [5] 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. - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2013 - Randwick
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
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
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Strasbourg
Country [8] 0 0
France
State/province [8] 0 0
Suresnes
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Gera
Country [11] 0 0
Germany
State/province [11] 0 0
Halle
Country [12] 0 0
Germany
State/province [12] 0 0
Heidelberg
Country [13] 0 0
Germany
State/province [13] 0 0
Koln
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Hungary
State/province [15] 0 0
Gyor
Country [16] 0 0
Italy
State/province [16] 0 0
Bari
Country [17] 0 0
Italy
State/province [17] 0 0
Firenze
Country [18] 0 0
Italy
State/province [18] 0 0
Monza
Country [19] 0 0
Italy
State/province [19] 0 0
Torino
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Cheongju
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Ulsan-si
Country [23] 0 0
Poland
State/province [23] 0 0
Krakow
Country [24] 0 0
Poland
State/province [24] 0 0
Lodz
Country [25] 0 0
Poland
State/province [25] 0 0
Olsztyn
Country [26] 0 0
Poland
State/province [26] 0 0
Poznan
Country [27] 0 0
Poland
State/province [27] 0 0
Warszawa
Country [28] 0 0
Romania
State/province [28] 0 0
Baia Mare
Country [29] 0 0
Romania
State/province [29] 0 0
Cluj-Napoca
Country [30] 0 0
Romania
State/province [30] 0 0
Craiova
Country [31] 0 0
Russian Federation
State/province [31] 0 0
St Petersburg
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Volzhsky
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Pamplona
Country [36] 0 0
Spain
State/province [36] 0 0
Sevilla
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taichung
Country [38] 0 0
Taiwan
State/province [38] 0 0
Tainan
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei
Country [40] 0 0
Ukraine
State/province [40] 0 0
Dnipropetrovsk
Country [41] 0 0
Ukraine
State/province [41] 0 0
Kharkiv
Country [42] 0 0
Ukraine
State/province [42] 0 0
Kriviy Rig
Country [43] 0 0
Ukraine
State/province [43] 0 0
Vinnitsa

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/NCT02450539