18 and older, any sex, with Advanced Cancer. 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.
Number of Participants With Clinically Significant EffectsPrimary· Baseline up to 233 weeks
The number of participants with clinically significant findings in the study were reported in this outcome measure.
Group
Value
95% CI
Part A - Cohort 1: 50 mg Abemaciclib - Q24H
0
Part A - Cohort 2: 100 mg Abemaciclib - Q24H
0
Part A - Cohort 3: 150 mg Abemaciclib - Q24H
0
Part A - Cohort 4: 225 mg Abemaciclib - Q24H
0
Part A - Cohort 5: 75 mg Abemaciclib - Q12H
0
Part A - Cohort 6: 100 mg Abemaciclib - Q12H
0
Part A - Cohort 7: 150 mg Abemaciclib - Q12H
0
Part A - Cohort 8: 200 mg Abemaciclib - Q12H
1
Part A - Cohort 9: 275 mg Abemaciclib - Q12H
2
Part B - 150 mg Abemaciclib - Q12H
1
Part B - 200 mg Abemaciclib - Q12H
5
Part C - 150 mg Abemaciclib - Q12H
0
Percentage of Participants With Tumor Response - Overall Response Rate (ORR), Disease Control Rate (DCR)Secondary· Baseline through Study Completion (Up to 285 weeks)
ORR is the percentage of participants who exhibit a confirmed complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
DCR is defined as the percentage of participants in the analysis population who e
ORR
Group
Value
95% CI
Part B - 150 mg Abemaciclib - Q12H
3.8
0.1 – 19.6
Part B - 200 mg Abemaciclib - Q12H
2.4
0.1 – 12.6
Part C - 150 mg Abemaciclib - Q12H
0
NA – NA
Part C - 200 mg Abemaciclib - Q12H
0
NA – NA
Part D - 150 mg Abemaciclib - Q12H
32.0
14.9 – 53.5
Part D - 200 mg Abemaciclib - Q12H
18.2
5.2 – 40.3
Part E - 150 mg Abemaciclib - Q12H
0
NA – NA
Part E - 200 mg Abemaciclib - Q12H
7.7
0.2 – 36.0
Part F - 150 mg Abemaciclib - Q12H
0
NA – NA
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant (Measurable Disease)
45.5
16.7 – 76.6
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant (Non-measurable Disease)
0
NA – NA
DCR
Group
Value
95% CI
Part B - 150 mg Abemaciclib - Q12H
42.3
23.4 – 63.1
Part B - 200 mg Abemaciclib - Q12H
52.4
36.4 – 68.0
Part C - 150 mg Abemaciclib - Q12H
0
NA – NA
Part C - 200 mg Abemaciclib - Q12H
20
4.3 – 48.1
Part D - 150 mg Abemaciclib - Q12H
68.0
46.5 – 85.1
Part D - 200 mg Abemaciclib - Q12H
72.7
49.8 – 89.3
Part E - 150 mg Abemaciclib - Q12H
23.1
5.0 – 53.8
Part E - 200 mg Abemaciclib - Q12H
30.8
9.1 – 61.4
Part F - 150 mg Abemaciclib - Q12H
13.3
1.7 – 40.5
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant (Measurable Disease)
72.7
39.0 – 94.0
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant (Non-measurable Disease)
87.5
47.3 – 99.7
Pharmacokinetics (PK): Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of AbemaciclibSecondary· Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1
PK: Cmax,ss of Abemaciclib.
Group
Value
95% CI
50 mg Abemaciclib - Q24H
NA
± NA
100 mg Abemaciclib - Q24H
102
± 198
150 mg Abemaciclib - Q24H
189
± 35
225 mg Abemaciclib - Q24H
121
± 38
75 mg Abemaciclib - Q12H
58.7
± 37
100 mg Abemaciclib - Q12H
226
± 51
150 mg Abemaciclib - Q12H
249
± 86
200 mg Abemaciclib - Q12H
298
± 72
PK: Area Under the Steady State Plasma Concentration-time Curve Over 24 Hours (AUC 0-24hr,ss) of AbemaciclibSecondary· Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1
PK: AUC 0-24hr,ss of Abemaciclib.
Group
Value
95% CI
50 mg Abemaciclib - Q24H
NA
± NA
100 mg Abemaciclib - Q24H
1840
± 172
150 mg Abemaciclib - Q24H
NA
± NA
225 mg Abemaciclib - Q24H
NA
± NA
75 mg Abemaciclib - Q12H
1300
± 49
100 mg Abemaciclib - Q12H
3910
± 53
150 mg Abemaciclib - Q12H
4280
± 94
200 mg Abemaciclib - Q12H
5520
± 70
Part A: Recommended Dose for Phase 2 StudiesSecondary· Baseline through Study Completion (Up to 285 weeks)
The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from the study.
Group
Value
95% CI
Part A - Abemaciclib
200
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through End of Treatment (Up to 645 weeks).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part A - Cohort 1: 50 mg Abemaciclib - Q24H
Serious: 0/4 (0%)
Deaths: 0/4
Part A - Cohort 2: 100 mg Abemaciclib - Q24H
Serious: 1/3 (33%)
Deaths: 0/3
Part A - Cohort 3: 150 mg Abemaciclib - Q24H
Serious: 1/3 (33%)
Deaths: 0/3
Part A - Cohort 4: 225 mg Abemaciclib - Q24H
Serious: 0/3 (0%)
Deaths: 0/3
Part A - Cohort 5: 75 mg Abemaciclib - Q12H
Serious: 1/3 (33%)
Deaths: 0/3
Part A - Cohort 6: 100 mg Abemaciclib - Q12H
Serious: 1/4 (25%)
Deaths: 0/4
Part A - Cohort 7: 150 mg Abemaciclib - Q12H
Serious: 1/3 (33%)
Deaths: 0/3
Part A - Cohort 8: 200 mg Abemaciclib - Q12H
Serious: 1/7 (14%)
Deaths: 0/7
Part A - Cohort 9: 275 mg Abemaciclib - Q12H
Serious: 1/3 (33%)
Deaths: 1/3
Part B - 150 mg Abemaciclib - Q12H
Serious: 7/26 (27%)
Deaths: 3/26
Part B - 200 mg Abemaciclib - Q12H
Serious: 15/42 (36%)
Deaths: 15/42
Part C - 150 mg Abemaciclib - Q12H
Serious: 1/2 (50%)
Deaths: 0/2
Part C - 200 mg Abemaciclib - Q12H
Serious: 3/15 (20%)
Deaths: 7/15
Part D - 150 mg Abemaciclib - Q12H
Serious: 5/25 (20%)
Deaths: 4/25
Part D - 200 mg Abemaciclib - Q12H
Serious: 7/22 (32%)
Deaths: 0/22
Part E - 150 mg Abemaciclib - Q12H
Serious: 5/13 (38%)
Deaths: 1/13
Part E - 200 mg Abemaciclib - Q12H
Serious: 5/13 (38%)
Deaths: 5/13
Part F - 150 mg Abemaciclib - Q12H
Serious: 3/15 (20%)
Deaths: 0/15
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant
Serious: 4/19 (21%)
Deaths: 2/19
Serious adverse events (70 terms)
Reaction
System
Part A - Cohort 1: 50 mg A…
Part A - Cohort 2: 100 mg …
Part A - Cohort 3: 150 mg …
Part A - Cohort 4: 225 mg …
Part A - Cohort 5: 75 mg A…
Part A - Cohort 6: 100 mg …
Part A - Cohort 7: 150 mg …
Part A - Cohort 8: 200 mg …
Part A - Cohort 9: 275 mg …
Part B - 150 mg Abemacicli…
Part B - 200 mg Abemacicli…
Part C - 150 mg Abemacicli…
Part C - 200 mg Abemacicli…
Part D - 150 mg Abemacicli…
Part D - 200 mg Abemacicli…
Part E - 150 mg Abemacicli…
Part E - 200 mg Abemacicli…
Part F - 150 mg Abemacicli…
Part G - 200 mg Abemacicli…
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Pericardial effusion
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Sinus tachycardia
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Duodenitis
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Gastric antral vascular ectasia
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Pneumatosis intestinalis
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Rectal haemorrhage
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Chills
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Non-cardiac chest pain
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Abdominal wall abscess
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Abscess
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Bronchitis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Other adverse events (521 terms — click to expand)
Reaction
System
Part A - Cohort 1: 50 mg A…
Part A - Cohort 2: 100 mg …
Part A - Cohort 3: 150 mg …
Part A - Cohort 4: 225 mg …
Part A - Cohort 5: 75 mg A…
Part A - Cohort 6: 100 mg …
Part A - Cohort 7: 150 mg …
Part A - Cohort 8: 200 mg …
Part A - Cohort 9: 275 mg …
Part B - 150 mg Abemacicli…
Part B - 200 mg Abemacicli…
Part C - 150 mg Abemacicli…
Part C - 200 mg Abemacicli…
Part D - 150 mg Abemacicli…
Part D - 200 mg Abemacicli…
Part E - 150 mg Abemacicli…
Part E - 200 mg Abemacicli…
Part F - 150 mg Abemacicli…
Part G - 200 mg Abemacicli…
Fatigue
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Hypertension
Vascular disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Cough
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Insomnia
Psychiatric disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Gastrooesophageal reflux disease
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Sinus tachycardia
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Hyperglycaemia
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Anxiety
Psychiatric disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Depression
Psychiatric disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Weight decreased
Investigations
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Hypoalbuminaemia
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to determine a safe dose of Abemaciclib to be given to participants with advanced cancer and to determine any side effects that may be associated with Abemaciclib in this population. Efficacy measures will be used to assess the activity of Abemaciclib in this population.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer
· 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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Currently open trials in the same condition.
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· active not recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 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: 19 September 2024
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/NCT01394016.