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NCT01394016

A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

Completed Phase 1 Results posted Last updated 19 September 2024
What this trial tests

Phase 1 trial testing Abemaciclib in Advanced Cancer in 225 participants. Completed in 12 April 2022.

Timeline
7 December 2009
Primary endpoint
29 May 2014
12 April 2022

Quick facts

Lead sponsorEli Lilly and Company
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment225
Start date7 December 2009
Primary completion29 May 2014
Estimated completion12 April 2022
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

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 Effects Primary · Baseline up to 233 weeks

The number of participants with clinically significant findings in the study were reported in this outcome measure.

GroupValue95% CI
Part A - Cohort 1: 50 mg Abemaciclib - Q24H0
Part A - Cohort 2: 100 mg Abemaciclib - Q24H0
Part A - Cohort 3: 150 mg Abemaciclib - Q24H0
Part A - Cohort 4: 225 mg Abemaciclib - Q24H0
Part A - Cohort 5: 75 mg Abemaciclib - Q12H0
Part A - Cohort 6: 100 mg Abemaciclib - Q12H0
Part A - Cohort 7: 150 mg Abemaciclib - Q12H0
Part A - Cohort 8: 200 mg Abemaciclib - Q12H1
Part A - Cohort 9: 275 mg Abemaciclib - Q12H2
Part B - 150 mg Abemaciclib - Q12H1
Part B - 200 mg Abemaciclib - Q12H5
Part C - 150 mg Abemaciclib - Q12H0
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
GroupValue95% CI
Part B - 150 mg Abemaciclib - Q12H3.80.1 – 19.6
Part B - 200 mg Abemaciclib - Q12H2.40.1 – 12.6
Part C - 150 mg Abemaciclib - Q12H0NA – NA
Part C - 200 mg Abemaciclib - Q12H0NA – NA
Part D - 150 mg Abemaciclib - Q12H32.014.9 – 53.5
Part D - 200 mg Abemaciclib - Q12H18.25.2 – 40.3
Part E - 150 mg Abemaciclib - Q12H0NA – NA
Part E - 200 mg Abemaciclib - Q12H7.70.2 – 36.0
Part F - 150 mg Abemaciclib - Q12H0NA – NA
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant (Measurable Disease)45.516.7 – 76.6
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant (Non-measurable Disease)0NA – NA
DCR
GroupValue95% CI
Part B - 150 mg Abemaciclib - Q12H42.323.4 – 63.1
Part B - 200 mg Abemaciclib - Q12H52.436.4 – 68.0
Part C - 150 mg Abemaciclib - Q12H0NA – NA
Part C - 200 mg Abemaciclib - Q12H204.3 – 48.1
Part D - 150 mg Abemaciclib - Q12H68.046.5 – 85.1
Part D - 200 mg Abemaciclib - Q12H72.749.8 – 89.3
Part E - 150 mg Abemaciclib - Q12H23.15.0 – 53.8
Part E - 200 mg Abemaciclib - Q12H30.89.1 – 61.4
Part F - 150 mg Abemaciclib - Q12H13.31.7 – 40.5
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant (Measurable Disease)72.739.0 – 94.0
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant (Non-measurable Disease)87.547.3 – 99.7
Pharmacokinetics (PK): Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib Secondary · Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1

PK: Cmax,ss of Abemaciclib.

GroupValue95% CI
50 mg Abemaciclib - Q24HNA± NA
100 mg Abemaciclib - Q24H102± 198
150 mg Abemaciclib - Q24H189± 35
225 mg Abemaciclib - Q24H121± 38
75 mg Abemaciclib - Q12H58.7± 37
100 mg Abemaciclib - Q12H226± 51
150 mg Abemaciclib - Q12H249± 86
200 mg Abemaciclib - Q12H298± 72
PK: Area Under the Steady State Plasma Concentration-time Curve Over 24 Hours (AUC 0-24hr,ss) of Abemaciclib Secondary · Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1

PK: AUC 0-24hr,ss of Abemaciclib.

GroupValue95% CI
50 mg Abemaciclib - Q24HNA± NA
100 mg Abemaciclib - Q24H1840± 172
150 mg Abemaciclib - Q24HNA± NA
225 mg Abemaciclib - Q24HNA± NA
75 mg Abemaciclib - Q12H1300± 49
100 mg Abemaciclib - Q12H3910± 53
150 mg Abemaciclib - Q12H4280± 94
200 mg Abemaciclib - Q12H5520± 70
Part A: Recommended Dose for Phase 2 Studies Secondary · 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.

GroupValue95% CI
Part A - Abemaciclib200

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)

ReactionSystemPart 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…
AnaemiaBlood and lymphatic system disorders
PneumoniaInfections and infestations
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
Febrile neutropeniaBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
Myocardial infarctionCardiac disorders
Pericardial effusionCardiac disorders
Sinus tachycardiaCardiac disorders
ColitisGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
DuodenitisGastrointestinal disorders
Gastric antral vascular ectasiaGastrointestinal disorders
NauseaGastrointestinal disorders
Pneumatosis intestinalisGastrointestinal disorders
Rectal haemorrhageGastrointestinal disorders
Small intestinal obstructionGastrointestinal disorders
VomitingGastrointestinal disorders
ChillsGeneral disorders
Non-cardiac chest painGeneral disorders
PyrexiaGeneral disorders
Abdominal wall abscessInfections and infestations
AbscessInfections and infestations
BronchitisInfections and infestations
CellulitisInfections and infestations
Other adverse events (521 terms — click to expand)

ReactionSystemPart 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…
FatigueGeneral disorders
NauseaGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
ConstipationGastrointestinal disorders
AnaemiaBlood and lymphatic system disorders
Decreased appetiteMetabolism and nutrition disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
HypertensionVascular disorders
CoughRespiratory, thoracic and mediastinal disorders
VomitingGastrointestinal disorders
InsomniaPsychiatric disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
Back painMusculoskeletal and connective tissue disorders
Sinus tachycardiaCardiac disorders
DehydrationMetabolism and nutrition disorders
HyperglycaemiaMetabolism and nutrition disorders
AnxietyPsychiatric disorders
DepressionPsychiatric disorders
Weight decreasedInvestigations
HypoalbuminaemiaMetabolism and nutrition disorders
Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral sensory neuropathyNervous system disorders
ThrombocytopeniaBlood and lymphatic system disorders
DyspepsiaGastrointestinal disorders
Drug hypersensitivityImmune system disorders
HyperlipidaemiaMetabolism and nutrition disorders
HeadacheNervous system disorders
Blood alkaline phosphatase increasedInvestigations
NeutropeniaBlood and lymphatic system disorders
Abdominal painGastrointestinal disorders
Oedema peripheralGeneral disorders
Blood creatinine increasedInvestigations
HypokalaemiaMetabolism and nutrition disorders
HyponatraemiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
LeukopeniaBlood and lymphatic system disorders
Seasonal allergyImmune system disorders
Lymphocyte count decreasedInvestigations
AphasiaNervous system disorders

Most-reported serious reactions: Anaemia, Pneumonia, Pulmonary embolism, Febrile neutropenia, Neutropenia, Thrombocytopenia, Myocardial infarction, Pericardial effusion.

Data from ClinicalTrials.gov NCT01394016 adverse events section.

Sponsor's own description

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):

  1. Cell cycle proteins as promising targets in cancer therapy.
    Otto T, Sicinski P. · · 2017 · cited 1412× · PMID 28127048 · DOI 10.1038/nrc.2016.138
  2. Targeting CDK4 and CDK6: From Discovery to Therapy.
    Sherr CJ, Beach D, Shapiro GI. · · 2016 · cited 729× · PMID 26658964 · DOI 10.1158/2159-8290.cd-15-0894
  3. Cyclin D1, cancer progression, and opportunities in cancer treatment.
    Qie S, Diehl JA. · · 2016 · cited 527× · PMID 27695879 · DOI 10.1007/s00109-016-1475-3
  4. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine.
    Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, et al · · 2014 · cited 411× · PMID 24919854 · DOI 10.1007/s10637-014-0120-7
  5. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
    Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
  6. CDK4 and CDK6 kinases: From basic science to cancer therapy.
    Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495
  7. Ribociclib (LEE011): Mechanism of Action and Clinical Impact of This Selective Cyclin-Dependent Kinase 4/6 Inhibitor in Various Solid Tumors.
    Tripathy D, Bardia A, Sellers WR. · · 2017 · cited 184× · PMID 28351928 · DOI 10.1158/1078-0432.ccr-16-3157
  8. Cell cycle regulation and anticancer drug discovery.
    Bai J, Li Y, Zhang G. · · 2017 · cited 182× · PMID 29372101 · DOI 10.20892/j.issn.2095-3941.2017.0033

Verify or expand the search:

Other trials of Abemaciclib

Trials testing the same drug.

Other recruiting trials for Advanced Cancer

Currently open trials in the same condition.

Other Eli Lilly and Company trials

Trials by the same sponsor.

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing