Pancreatic Ductal AdenocarcinomaPhase 2NCT02981342

A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

A Phase 2 study testing Abemaciclib, LY3023414 and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by Eli Lilly and Company at 32 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Ductal Adenocarcinoma
What is being tested?: Abemaciclib, LY3023414 and Gemcitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 32 sitesin 8 countries
Study dates: 12 Jan 2017to 9 Nov 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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).

Trial locations and contacts

32 sites in 8 countries.

Country

City, postcode or hospital

32 sites in 8 countries

United States10 sites

Research Medical Center
Kansas City, Missouri, 64132
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, 53792-4108
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Yale University School of Medicine
New Haven, Connecticut, 06510
Seattle Cancer Care Alliance
Olympia, Washington, 98109
Illinois CancerCare
Peoria, Illinois, 61615
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Virginia Mason Medical Center
Seattle, Washington, 98101

Other trials in United States

Spain5 sites

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, 08036
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, 08908
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.
Madrid, 28040
Fundacion Jimenez Diaz
Madrid, 28040
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, 29010

Other trials in Spain

Belgium4 sites

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, 1200
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.
Edegem, 2650
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, 3000
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, 2610

Other trials in Belgium

Taiwan4 sites

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.
Tainan, 70403
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, 10048
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, 11217
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

Other trials in Taiwan

France3 sites

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.
Lyon, 69373
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.
Paris, 75014
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.
Pessac, 33604

Other trials in France

Israel3 sites

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.
Haifa, 3109601
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.
Ramat Gan, 5262000
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.
Tel Aviv, 6423906

Other trials in Israel

Australia2 sites

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, 2148
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, 2010

Other trials in Australia

United Kingdom1 site

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, NW1 2BU

Other trials in United Kingdom

About this study

Official 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

Conditions: Pancreatic Ductal Adenocarcinoma
Being tested: Abemaciclib, LY3023414, Gemcitabine, Capecitabine
Keywords: pancreatic cancer
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbemaciclibDrug
Also called LY2835219
Administered orally
LY3023414Drug
Administered orally
GemcitabineDrug
Also called LY188011
Administered IV
CapecitabineDrug
Administered orally

Study groups in NCT02981342
Study group	Role	What they receive
Abemaciclib	Experimental	Abemaciclib given orally. Receives: Drug: Abemaciclib
Abemaciclib + LY3023414	Experimental	Abemaciclib given orally and LY3023414 given orally. Receives: Drug: Abemaciclib; Drug: LY3023414
Standard of Care (Gemcitabine or Capecitabine)	Experimental	Gemcitabine given intravenously (IV) OR capecitabine given orally. Receives: Drug: Gemcitabine; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
Stage 2: Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.
Measured: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)

Secondary outcomes (13)

Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR
Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Measured: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)
Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))
Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).
Measured: Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose
Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414
Measured: Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)
Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414
Measured: Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)
Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
Measured: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
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
Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions \& no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is 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. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
Measured: Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)
Stage 2: Duration of Response (DoR)
Measured: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)
Stage 2: Overall Survival (OS)
OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date.
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
Measured: Baseline to Death from Any Cause (Up to 10 Months)
Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
Measured: Baseline, 6 Months
Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes.
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
Measured: Baseline, 6 Months
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)
The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:
1. Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).
2. Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)
3. Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).
Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
Measured: Baseline, 6 Months
Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414
Mean steady state exposure was reported by trough pre-dose plasma concentrations.
Measured: C2D1: 0h, C3D1: 0h, C4D1: 0h
Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose
Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.
Measured: C1D1: 2h Post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 20179 Nov 2018

First posted5 Dec 2016 (estimated)
Study start12 Jan 2017
Primary completion20 Apr 2018
Study completion9 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02981342
Sponsor's protocol ID: 16342
Other IDs: I3Y-MC-JPCJ, 2016-002218-36, 2016
Status last verified: 18 Aug 2019
First submitted: 1 Dec 2016
Last updated: 20 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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
Expanded access: Available

Publications

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.
PubMed 37840530

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors

All Pancreatic Ductal Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02981342
Acronym / sponsor ID: 16342
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: pancreatic cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 12 Jan 2017 (actual)
Primary completion: 20 Apr 2018 (actual)
Study completion: 9 Nov 2018 (actual)
First posted: 5 Dec 2016 (estimated)
Results: Posted 25 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Abemaciclib	Experimental	Drug: AbemaciclibAbemaciclib given orally.
Abemaciclib + LY3023414	Experimental	Drug: Abemaciclib, Drug: LY3023414Abemaciclib given orally and LY3023414 given orally.
Standard of Care (Gemcitabine or Capecitabine)	Experimental	Drug: Gemcitabine, Drug: CapecitabineGemcitabine given intravenously (IV) OR capecitabine given orally.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AbemaciclibAlso: LY2835219Administered orally	Drug	Abemaciclib, Abemaciclib + LY3023414
LY3023414Administered orally	Drug	Abemaciclib + LY3023414
GemcitabineAlso: LY188011Administered IV	Drug	Standard of Care (Gemcitabine or Capecitabine)
CapecitabineAdministered orally	Drug	Standard of Care (Gemcitabine or Capecitabine)

Primary outcome

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)
Time frame: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Stage 2: Progression Free Survival (PFS)
Time frame: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)
PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.

13 secondary outcomes

Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR
Time frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)
Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))
Time frame: Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose
Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414
Time frame: Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)
Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414
Time frame: Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)
Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
Time frame: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
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
Time frame: Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)
Stage 2: Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)
Stage 2: Overall Survival (OS)
Time frame: Baseline to Death from Any Cause (Up to 10 Months)
Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level
Time frame: Baseline, 6 Months
Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Time frame: Baseline, 6 Months
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)
Time frame: Baseline, 6 Months
Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414
Time frame: C2D1: 0h, C3D1: 0h, C4D1: 0h
Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose
Time frame: C1D1: 2h Post dose

Results and safety

Results posted to the registry on 25 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)	7	7
200mg Abemaciclib	33	22
150mg Abemaciclib + 150mg LY3023414	33	20
Gemcitabine or Capecitabine	33	19

Primary outcome: 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)

Time frame: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months). Number (95% Confidence Interval). Unit: percentage of Participants

Measure	200mg Abemaciclib n = 33	150mg Abemaciclib + 150mg LY3023414 n = 33	Gemcitabine or Capecitabine n = 33
Value	15.2 (2.9 to 27.4)	12.1 (1.0 to 23.3)	36.4 (20 to 52.8)

200mg Abemaciclib vs Gemcitabine or Capecitabine: p = 0.0495, Cochran-Mantel-Haenszel
150mg Abemaciclib + 150mg LY3023414 vs Gemcitabine or Capecitabine: p = 0.0230, Cochran-Mantel-Haenszel

Population analysed: All randomized participants.

Primary outcome: Stage 2: Progression Free Survival (PFS)

Time frame: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months). Median (95% Confidence Interval). Unit: Months

Measure	200mg Abemaciclib n = 33	150mg Abemaciclib + 150mg LY3023414 n = 33	Gemcitabine or Capecitabine n = 33
Value	1.68 (1.35 to 1.84)	1.81 (1.28 to 1.91)	3.25 (1.05 to 5.65)

200mg Abemaciclib vs Gemcitabine or Capecitabine: p = 0.0085, Log Rank
150mg Abemaciclib + 150mg LY3023414 vs Gemcitabine or Capecitabine: p = 0.0123, Log Rank

Population analysed: All randomized participants. Censored participants: Abemaciclib 200 mg: 3, Abemaciclib 150mg + LY3023414 150mg: 8, Gemcitabine \& Capecitabine: 18; No participants were enrolled in stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled in stage 1.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
150mg Abemaciclib + 150mg Galunisertib (Safety Lead - In)	4 of 7 (57.1%)	7 of 7 (100%)	5 of 7
200mg Abemaciclib	17 of 32 (53.1%)	30 of 32 (93.8%)	22 of 32
150mg Abemaciclib + 150mg LY3023414	18 of 33 (54.5%)	33 of 33 (100%)	21 of 33
Gemcitabine or Capecitabine	15 of 26 (57.7%)	25 of 26 (96.2%)	12 of 26

Limitations and caveats (from the sponsor): Study was planned for stage 1 \& stage 2. Stage 2 did not occur, no participants were enrolled to stage 2;

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37840530Chiorean 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.
A Study of Abemaciclib (LY2835219) Alone or in Combination with Other Agents in Participants with Previously Treated Pancreatic Ductal AdenocarcinomaLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

Related trials for Pancreatic Ductal Adenocarcinoma

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

32 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib, LY3023414 and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by Eli Lilly and Company at 32 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Spain, Belgium, Taiwan, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02981342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.