A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma
NCT ID: NCT02981342
Last Updated: 2019-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2017-01-12
2018-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Abemaciclib
Abemaciclib given orally.
Abemaciclib
Administered orally
Abemaciclib + LY3023414
Abemaciclib given orally and LY3023414 given orally.
Abemaciclib
Administered orally
LY3023414
Administered orally
Standard of Care (Gemcitabine or Capecitabine)
Gemcitabine given intravenously (IV) OR capecitabine given orally.
Gemcitabine
Administered IV
Capecitabine
Administered orally
Interventions
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Abemaciclib
Administered orally
LY3023414
Administered orally
Gemcitabine
Administered IV
Capecitabine
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Illinois CancerCare
Peoria, Illinois, United States
Research Medical Center
Kansas City, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Seattle Cancer Care Alliance
Olympia, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, United States
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, , Australia
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, , Australia
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.
Brussels, , Belgium
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Edegem, , Belgium
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.
Leuven, , Belgium
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.
Wilrijk, , Belgium
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Lyon, , France
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Paris, , France
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Pessac, , France
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Haifa, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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.
Barcelona, , Spain
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.
L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
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.
Málaga, , Spain
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Tainan City, , Taiwan
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Taipei, , Taiwan
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.
Taipei, , Taiwan
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.
Taipei, , Taiwan
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.
London, , United Kingdom
Countries
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References
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Chiorean EG, Picozzi V, Li CP, Peeters M, Maurel J, Singh J, Golan T, Blanc JF, Chapman SC, Hussain AM, Johnston EL, Hochster HS. Efficacy and safety of abemaciclib alone and with PI3K/mTOR inhibitor LY3023414 or galunisertib versus chemotherapy in previously treated metastatic pancreatic adenocarcinoma: A randomized controlled trial. Cancer Med. 2023 Oct;12(20):20353-20364. doi: 10.1002/cam4.6621. Epub 2023 Oct 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Abemaciclib (LY2835219) Alone or in Combination with Other Agents in Participants with Previously Treated Pancreatic Ductal Adenocarcinoma
Other Identifiers
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I3Y-MC-JPCJ
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002218-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16342
Identifier Type: -
Identifier Source: org_study_id
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