18 and older, any sex, with Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· 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 progres
Group
Value
95% CI
200mg Abemaciclib
15.2
2.9 – 27.4
150mg Abemaciclib + 150mg LY3023414
12.1
1.0 – 23.3
Gemcitabine or Capecitabine
36.4
20 – 52.8
Stage 2: Progression Free Survival (PFS)Primary· 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 no
Group
Value
95% CI
200mg Abemaciclib
1.68
1.35 – 1.84
150mg Abemaciclib + 150mg LY3023414
1.81
1.28 – 1.91
Gemcitabine or Capecitabine
3.25
1.05 – 5.65
Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PRSecondary· Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)
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.
Group
Value
95% CI
200mg Abemaciclib
3
0 – 8.9
150mg Abemaciclib + 150mg LY3023414
0
NA – NA
Gemcitabine or Capecitabine
3
0 – 8.9
Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))Secondary· Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose
Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).
Abemaciclib
Group
Value
95% CI
150mg Abemaciclib + 150mg Galunisertib
356
± 137
LSN2839567 (M2)
Group
Value
95% CI
150mg Abemaciclib + 150mg Galunisertib
85.1
± 66
LSN3106726 (M20)
Group
Value
95% CI
150mg Abemaciclib + 150mg Galunisertib
153
± 58
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 MonthsSecondary· Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 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 defi
Group
Value
95% CI
200mg Abemaciclib
3
0 – 8.9
150mg Abemaciclib + 150mg LY3023414
0
0 – 0
Gemcitabine or Capecitabine
3
0 – 8.9
Stage 2: Overall Survival (OS)Secondary· Baseline to Death from Any Cause (Up to 10 Months)
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.
Group
Value
95% CI
200mg Abemaciclib
2.71
1.97 – 5.36
150mg Abemaciclib + 150mg LY3023414
3.29
1.97 – 5.03
Gemcitabine or Capecitabine
NA
2.53 – NA
Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) LevelSecondary· Baseline, 6 Months
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.
Group
Value
95% CI
200mg Abemaciclib
4281.53
± 8177.89
150mg Abemaciclib + 150mg LY3023414
3225.29
± 5730.25
Gemcitabine or Capecitabine
-501.17
± 7198.70
Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)Secondary· Baseline, 6 Months
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 completel
Pain at its Worst in Last 24 hours
Group
Value
95% CI
200mg Abemaciclib
0.63
± 0.47
150mg Abemaciclib + 150mg LY3023414
-0.33
± 0.55
Gemcitabine or Capecitabine
-0.02
± 0.57
Pain at its Least in Last 24 hours
Group
Value
95% CI
200mg Abemaciclib
0.86
± 0.42
150mg Abemaciclib + 150mg LY3023414
0.18
± 0.49
Gemcitabine or Capecitabine
0.39
± 0.51
Pain on the Average
Group
Value
95% CI
200mg Abemaciclib
0.62
± 0.45
150mg Abemaciclib + 150mg LY3023414
-0.03
± 0.51
Gemcitabine or Capecitabine
-0.07
± 0.53
Pain Right Now
Group
Value
95% CI
200mg Abemaciclib
0.38
± 0.34
150mg Abemaciclib + 150mg LY3023414
0.34
± 0.59
Gemcitabine or Capecitabine
-0.38
± 0.61
Pain Interfered General Activity
Group
Value
95% CI
200mg Abemaciclib
0.64
± 0.47
150mg Abemaciclib + 150mg LY3023414
0.07
± 0.55
Gemcitabine or Capecitabine
0.22
± 0.57
Pain Interfered with Mood
Group
Value
95% CI
200mg Abemaciclib
0.54
± 0.41
150mg Abemaciclib + 150mg LY3023414
0.28
± 0.48
Gemcitabine or Capecitabine
0.60
± 0.50
Pain Interfered Walking Ability
Group
Value
95% CI
200mg Abemaciclib
0.05
± 0.55
150mg Abemaciclib + 150mg LY3023414
0.83
± 0.64
Gemcitabine or Capecitabine
0.19
± 0.67
Pain Interfered with Normal Work
Group
Value
95% CI
200mg Abemaciclib
1.07
± 0.51
150mg Abemaciclib + 150mg LY3023414
0.66
± 0.59
Gemcitabine or Capecitabine
0.19
± 0.61
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)Secondary· Baseline, 6 Months
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
Global Health Status
Group
Value
95% CI
200mg Abemaciclib
-6.21
± 3.87
150mg Abemaciclib + 150mg LY3023414
-4.82
± 4.50
Gemcitabine or Capecitabine
-2.40
± 4.64
Functional Scales: Physical Functioning
Group
Value
95% CI
200mg Abemaciclib
-14.44
± 4.40
150mg Abemaciclib + 150mg LY3023414
-11.65
± 5.12
Gemcitabine or Capecitabine
-5.42
± 5.12
Functional Scales: Role Functioning
Group
Value
95% CI
200mg Abemaciclib
-17.09
± 6.17
150mg Abemaciclib + 150mg LY3023414
-18.05
± 7.32
Gemcitabine or Capecitabine
-17.10
± 7.36
Functional Scales: Emotional Functioning
Group
Value
95% CI
200mg Abemaciclib
-4.89
± 4.49
150mg Abemaciclib + 150mg LY3023414
-0.63
± 5.22
Gemcitabine or Capecitabine
2.06
± 5.41
Functional Scales: Cognitive Functioning
Group
Value
95% CI
200mg Abemaciclib
-10.43
± 4.10
150mg Abemaciclib + 150mg LY3023414
-8.39
± 4.77
Gemcitabine or Capecitabine
-5.18
± 4.95
Functional Scale: Social Functioning
Group
Value
95% CI
200mg Abemaciclib
-21.12
± 4.90
150mg Abemaciclib + 150mg LY3023414
-17.09
± 5.72
Gemcitabine or Capecitabine
-2.00
± 5.95
Symptom Scales: Fatigue
Group
Value
95% CI
200mg Abemaciclib
14.13
± 4.92
150mg Abemaciclib + 150mg LY3023414
14.90
± 5.73
Gemcitabine or Capecitabine
5.64
± 5.71
Symptom Scales: Nausea and Vomiting
Group
Value
95% CI
200mg Abemaciclib
7.98
± 5.57
150mg Abemaciclib + 150mg LY3023414
9.42
± 6.47
Gemcitabine or Capecitabine
11.88
± 6.50
Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414Secondary· C2D1: 0h, C3D1: 0h, C4D1: 0h
Mean steady state exposure was reported by trough pre-dose plasma concentrations.
Group
Value
95% CI
150mg Abemaciclib + 150mg LY3023414
27.3
± 450
Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-doseSecondary· C1D1: 2h Post dose
Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.
Group
Value
95% CI
150mg Abemaciclib + 150mg LY3023414
518
± 67
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 30 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
150mg Abemaciclib + 150mg Galunisertib (Safety Lead - In)
Serious: 4/7 (57%)
Deaths: 5/7
200mg Abemaciclib
Serious: 17/32 (53%)
Deaths: 22/32
150mg Abemaciclib + 150mg LY3023414
Serious: 18/33 (55%)
Deaths: 21/33
Gemcitabine or Capecitabine
Serious: 15/26 (58%)
Deaths: 12/26
Serious adverse events (62 terms)
Reaction
System
150mg Abemaciclib + 150mg …
200mg Abemaciclib
150mg Abemaciclib + 150mg …
Gemcitabine or Capecitabine
Vomiting
Gastrointestinal disorders
—
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
Stomatitis
Gastrointestinal disorders
—
—
—
—
Pyrexia
General disorders
—
—
—
—
Bile duct obstruction
Hepatobiliary disorders
—
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
—
—
Ascites
Gastrointestinal disorders
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
Duodenal stenosis
Gastrointestinal disorders
—
—
—
—
Gastric ulcer haemorrhage
Gastrointestinal disorders
—
—
—
—
Gastrointestinal perforation
Gastrointestinal disorders
—
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
—
Large intestinal obstruction
Gastrointestinal disorders
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
Obstruction gastric
Gastrointestinal disorders
—
—
—
—
Oesophagitis
Gastrointestinal disorders
—
—
—
—
Subileus
Gastrointestinal disorders
—
—
—
—
Asthenia
General disorders
—
—
—
—
Chills
General disorders
—
—
—
—
Fatigue
General disorders
—
—
—
—
General physical health deterioration
General disorders
—
—
—
—
Other adverse events (104 terms — click to expand)
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 3
· not yet recruiting
NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco
· Phase 2
· not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi
· Phase 2
· not yet recruiting
NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis
· Phase 1, PHASE2
· recruiting
NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer
· Phase 2
· enrolling by invitation
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 20 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02981342.