Trial · NCT02919696
A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers
NCT02919696, Phase 1, Completed, Eli Lilly and Company; results first posted 2020-09-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers. Trials, record NCT02919696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02919696
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers
- NCT number
- NCT02919696
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Advanced Cancer, Metastatic Cancer
- Interventions
- Abemaciclib
- First posted
- 2016-09-29
- Last updated
- 2020-09-25
- Results first posted
- 2020-09-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With One or More Drug Related Adverse Events | Baseline through End of Study (Up to 10 Months) | Number of participants with one or more drug related adverse events. Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites Single Dose | Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and its Metabolites following a single oral dose. |
| Secondary | PK: Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites (Twice Daily Dosing) | Cycle 1, Day(D) 31; Predose, 1, 2, 4, 6, 8, 10, 24 Hours Postdose | PK: Maximum Concentration (Cmax) of Abemaciclib and its Metabolites following a twice daily dosing. |
| Secondary | PK: Area Under Concentration Time Curve (AUC) From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites Single Dose | Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose | PK: Area Under Concentration Time Curve (AUC) from Time Zero to 12 hours (AUC \[0-12\]) of Abemaciclib and its Metabolites following a single oral dose. |
| Secondary | PK: AUC From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites (Twice Daily Dosing) | Cycle 1, Day(D) 31; Predose, 1, 2, 4, 6, 8, 10, 24 Hours Postdose | PK: AUC from Time Zero to 12 hours (AUC \[0-12\]) of Abemaciclib and its Metabolites following twice daily dosing |
| Secondary | PK: AUC From Time Zero to Infinity (AUC[0-inf]) of Abemaciclib and Its Metabolites Single Dose | Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose | PK: AUC from Time Zero to Infinity (AUC\[0-inf\]) of Abemaciclib and its Metabolites following a single oral dose. |
| Secondary | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline to Measured Progressive Disease (Up to 13 Months ) | ORR was defined as the percentage of randomized participants with a best overall response of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the 20% increase must be at least one lesion must increase by an absolute value of ≥5 mm to be considered progression. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With One or More Drug Related Adverse Events | Baseline through End of Study (Up to 10 Months) | All randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites Single Dose | Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose | All randomized participants who received at least one dose of study drug and had evaluable PK data. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites (Twice Daily Dosing) | Cycle 1, Day(D) 31; Predose, 1, 2, 4, 6, 8, 10, 24 Hours Postdose | All randomized participants who received at least one dose of study drug and had evaluable PK data. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Area Under Concentration Time Curve (AUC) From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites Single Dose | Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose | All randomized participants who received at least one dose of study drug and had evaluable PK data. | nanogram*hour/milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: AUC From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites (Twice Daily Dosing) | Cycle 1, Day(D) 31; Predose, 1, 2, 4, 6, 8, 10, 24 Hours Postdose | All randomized participants who received at least one dose of study drug and had evaluable PK data. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: AUC From Time Zero to Infinity (AUC[0-inf]) of Abemaciclib and Its Metabolites Single Dose | Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose | All randomized participants who received at least one dose of study drug and had evaluable PK data. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline to Measured Progressive Disease (Up to 13 Months ) | All randomized participants who received at least one dose of study drug and had PR/CR data. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With One or More Drug Related Adverse Events | Abemaciclib 150 mg | 12 | Participants | ||
| Number of Participants With One or More Drug Related Adverse Events | Abemaciclib 200 mg | 13 | Participants | ||
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites Single Dose | Abemaciclib 150 mg | 204 | Geometric Coefficient of Variation 70 | nanogram/milliliter (ng/mL) | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites Single Dose | Abemaciclib 200 mg | 210 | Geometric Coefficient of Variation 65 | nanogram/milliliter (ng/mL) | |
| PK: Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites (Twice Daily Dosing) | Abemaciclib 100 mg | 205 | Geometric Coefficient of Variation 64 | ng/mL | |
| PK: Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites (Twice Daily Dosing) | Abemaciclib 150 mg | 267 | Geometric Coefficient of Variation 71 | ng/mL | |
| PK: Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites (Twice Daily Dosing) | Abemaciclib 200 mg | 320 | Geometric Coefficient of Variation 91 | ng/mL | |
| PK: Area Under Concentration Time Curve (AUC) From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites Single Dose | Abemaciclib 150 mg | 1700 | Geometric Coefficient of Variation 75 | nanogram*hour/milliliter (ng*hr/mL) | |
| PK: Area Under Concentration Time Curve (AUC) From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites Single Dose | Abemaciclib 200 mg | 1740 | Geometric Coefficient of Variation 68 | nanogram*hour/milliliter (ng*hr/mL) | |
| PK: AUC From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites (Twice Daily Dosing) | Abemaciclib 100 mg | 2190 | Geometric Coefficient of Variation 65 | ng*hr/mL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abemaciclib 150 mg | 12 | |
| Overall Study | STARTED | Abemaciclib 200 mg | 14 | |
| Overall Study | Received at Least One Dose of Study Drug | Abemaciclib 150 mg | 12 | |
| Overall Study | Received at Least One Dose of Study Drug | Abemaciclib 200 mg | 13 | |
| Overall Study | PK 100 mg Abemaciclib Dose | Abemaciclib 150 mg | 5 | |
| Overall Study | PK 100 mg Abemaciclib Dose | Abemaciclib 200 mg | 0 | |
| Overall Study | PK 150 mg Abemaciclib Dose | Abemaciclib 150 mg | 0 | |
| Overall Study | PK 150 mg Abemaciclib Dose | Abemaciclib 200 mg | 2 | |
| Overall Study | Death On Treatment | Abemaciclib 150 mg | 1 | |
| Overall Study | Death On Treatment | Abemaciclib 200 mg | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Abemaciclib 150 mg | 6 | 12 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Abemaciclib 200 mg | 5 | 13 | 7 |
| other | Leukopenia | Blood and lymphatic system disorders | Abemaciclib 150 mg | 2 | 12 | 7 |
| other | Leukopenia | Blood and lymphatic system disorders | Abemaciclib 200 mg | 1 | 13 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Abemaciclib 150 mg | 1 | 12 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | Abemaciclib 200 mg | 1 | 13 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Abemaciclib 150 mg | 1 | 12 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Abemaciclib 200 mg | 0 | 13 | 0 |
| other | Palpitations | Cardiac disorders | Abemaciclib 150 mg | 0 | 12 | 0 |
| other | Palpitations | Cardiac disorders | Abemaciclib 200 mg | 1 | 13 | 1 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abemaciclib 150 mg | 6 | 12 |
| Total, all-cause mortality | Abemaciclib 200 mg | 1 | 13 |
| Total, other adverse events | Abemaciclib 150 mg | 12 | 12 |
| Total, other adverse events | Abemaciclib 200 mg | 13 | 13 |
| Total, serious adverse events | Abemaciclib 150 mg | 2 | 12 |
| Total, serious adverse events | Abemaciclib 200 mg | 4 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33492568 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Abemaciclib 150 mg vs Abemaciclib 200 mg: Number of Participants With One or More Drug Related Adverse Events | Trial comparisons |
| Abemaciclib 150 mg vs Abemaciclib 200 mg: deaths from any cause | Trial comparisons |
| Abemaciclib 150 mg vs Abemaciclib 200 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02919696
GET https://conductscience.org/api/trials/v1/NCT02919696/events?page=2