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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02981342




Registration number
NCT02981342
Ethics application status
Date submitted
1/12/2016
Date registered
5/12/2016

Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma
Scientific title
An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma
Secondary ID [1] 0 0
I3Y-MC-JPCJ
Secondary ID [2] 0 0
16342
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Ductal Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Treatment: Drugs - LY3023414
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Capecitabine

Experimental: Abemaciclib - Abemaciclib given orally.

Experimental: Abemaciclib + LY3023414 - Abemaciclib given orally and LY3023414 given orally.

Experimental: Standard of Care (Gemcitabine or Capecitabine) - Gemcitabine given intravenously (IV) OR capecitabine given orally.


Treatment: Drugs: Abemaciclib
Administered orally

Treatment: Drugs: LY3023414
Administered orally

Treatment: Drugs: Gemcitabine
Administered IV

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

Outcomes
Primary outcome [1] 0 0
Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Timepoint [1] 0 0
Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
Primary outcome [2] 0 0
Stage 2: Progression Free Survival (PFS)
Timepoint [2] 0 0
Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)
Secondary outcome [1] 0 0
Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR
Timepoint [1] 0 0
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)
Secondary outcome [2] 0 0
Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))
Timepoint [2] 0 0
Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose
Secondary outcome [3] 0 0
Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414
Timepoint [3] 0 0
Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)
Secondary outcome [4] 0 0
Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414
Timepoint [4] 0 0
Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)
Secondary outcome [5] 0 0
Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
Timepoint [5] 0 0
Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
Secondary outcome [6] 0 0
Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months
Timepoint [6] 0 0
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)
Secondary outcome [7] 0 0
Stage 2: Duration of Response (DoR)
Timepoint [7] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)
Secondary outcome [8] 0 0
Stage 2: Overall Survival (OS)
Timepoint [8] 0 0
Baseline to Death from Any Cause (Up to 10 Months)
Secondary outcome [9] 0 0
Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level
Timepoint [9] 0 0
Baseline, 6 Months
Secondary outcome [10] 0 0
Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Timepoint [10] 0 0
Baseline, 6 Months
Secondary outcome [11] 0 0
Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Timepoint [11] 0 0
Baseline, 6 Months
Secondary outcome [12] 0 0
Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414
Timepoint [12] 0 0
C2D1: 0h, C3D1: 0h, C4D1: 0h
Secondary outcome [13] 0 0
Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose
Timepoint [13] 0 0
C1D1: 2h Post dose

Eligibility
Key inclusion criteria
* Histological or cytological diagnosis of ductal adenocarcinoma of the pancreas.
* Metastatic disease with documented disease progression following previous treatment with at least one, but no more than 2 prior therapies, with one of the prior therapies having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for localized resectable or unresectable PDAC each count as a line of therapy if multiagent chemotherapy regimens were administered (and neoadjuvant regimen was different than adjuvant regimen) and if the participant progressed with metastatic disease while taking or within 6 months of completion of (neo)adjuvant therapy.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participant for whom treatment with monotherapy chemotherapy such as gemcitabine or capecitabine is a reasonable choice.
* Discontinued all prior treatment for cancer at least 14 days prior to initial dose of study treatment.
* Adequate organ function.

* allow alanine aminotransferase (ALT) or aspartate aminotransferase (AST) up to 5x upper limit of normal (ULN) if liver metastases.
* allow bilirubin up to 2.5 times ULN if elevation is not associated with other signs of liver toxicity or can be explained by mechanical obstruction - requires clinical research physician approval.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior to study treatment initiation are eligible.
* Have insulin-dependent diabetes mellitus. Participants with type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%.
* Have symptomatic central nervous system metastasis. Screening of asymptomatic participants is not required for enrollment.
* Have had major surgery within 7 days prior to initiation of study drug to allow for postoperative healing of the surgical wound and site(s).
* Have previously received treatment with any cyclin-dependent kinase (CDK) 4 and 6 inhibitor or phosphatidylinositol 3-kinase (PI3K) and/or mammalian target of rapamycin (mTOR) inhibitor or have a known hypersensitivity to any component of the investigational products in this study.
* Have a known hypersensitivity to investigator's choice of standard of care (gemcitabine or capecitabine).

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
12/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/11/2018
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 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. - Blacktown
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. - Sydney
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
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 Hampshire
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
Country [10] 0 0
Belgium
State/province [10] 0 0
Edegem
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Wilrijk
Country [13] 0 0
France
State/province [13] 0 0
Lyon
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Pessac
Country [16] 0 0
Israel
State/province [16] 0 0
Haifa
Country [17] 0 0
Israel
State/province [17] 0 0
Ramat Gan
Country [18] 0 0
Israel
State/province [18] 0 0
Tel Aviv
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Hospitalet de Llobregat
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Malaga
Country [23] 0 0
Taiwan
State/province [23] 0 0
Tainan
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei city
Country [25] 0 0
Taiwan
State/province [25] 0 0
Taipei
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

More information provided by Eli Lilly and Company

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT02981342