CompletedNCT02014129Updated Aug 24, 2020Results posted

A Study of LY2835219 in Japanese Participants With Advanced Cancer

A Phase 1 interventional study of LY2835219 in Neoplasm Metastasis and Lymphoma, sponsored by Eli Lilly and Company. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-08-24.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.

Conditions studied

Neoplasm Metastasis
Lymphoma

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Neoplasm Metastasis 3,517

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 12 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

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Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Have histological or cytological evidence of a diagnosis of cancer (either a solid tumor or a lymphoma) that is advanced and/or metastatic
Must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease
Have the presence of measurable or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1, or the Revised Response Criteria for Malignant Lymphoma Guideline
Have adequate organ function
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, and investigational therapy, for at least 21 days before the first dose of study drug and recovered from the acute effects of any such therapy
Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug
Females with child bearing potential: must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.
A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 3 months after the last administration
Have an estimated life expectancy of ≥12 weeks
Are able to swallow capsules

Exclusion criteria

Exclusion Criteria:

Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication
Have a medical history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (e.g., ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest
Have a baseline with any of the following findings on screening electrocardiogram (ECG): ventricular tachycardia, ventricular fibrillation, abnormal QTc using Bazett's formula (QTcB) (defined as ≥470 milliseconds), or evidence of acute myocardial ischemia
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel)
Have symptomatic central nervous system (CNS) malignancy or metastasis. For asymptomatic participants without history of CNS malignancy or metastases
Have evidence or history of a leukemia
Have received a stem-cell transplant. As an exception, a participant with lymphoma who received an autologous stem-cell transplant is eligible for the study, if more than 75 days have passed before the initial dose of study drug
Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV], hepatitis B, or hepatitis C)

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
Cohort 1 - 100 mg Abemaciclib
100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Drug: LY2835219
Experimental
Cohort 2 - 150 mg Abemaciclib
150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Drug: LY2835219
Experimental
Cohort 3 - 200 mg Abemaciclib
200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Drug: LY2835219

Interventions

DrugLY2835219
Administered orally
Also known as: abemaciclib

What researchers measure

Primary outcomes

Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT)
DLT is defined as an adverse event between Day -3 and Day 29 of Cycle 1 that is possibly related to the study drug and fulfills any one of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Time frame: Cycle 1 = 32 days

Secondary outcomes

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib
Maximum plasma concentration on Day -3 and Day 28 of Cycle 1.
Time frame: Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hours (hr) postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days)
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of Abemaciclib
AUC on Day -3 and Day 28 of Cycle 1 are AUC from time zero to infinity \[AUC(0-∞)\] and AUC during one dosing interval at steady state (AUCτ,ss), respectively.
Time frame: Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hr postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days)
Percentage of Participants With a Tumor Response: Objective Response Rate (ORR)
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
Time frame: Baseline to Measured Progressive Disease (Up To 24 months)

Results

Posted Aug 24, 2020

Participant flow

Participants completed the trial if they received at least one dose of study drug and met discontinuation criteria.

Participant flow — Overall Study
Milestone	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Started	3	3	6
Received at least one dose of study drug	3	3	6
Completed	3	3	6
Not completed	0	0	0

Outcome measures

PrimaryNumber of Participants With Abemaciclib Dose-Limiting Toxicity (DLT)

DLT is defined as an adverse event between Day -3 and Day 29 of Cycle 1 that is possibly related to the study drug and fulfills any one of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

Time frame:: Cycle 1 = 32 days
Reported as:: Count of participants · Participants

Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT)
Participants	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT)	0	0	1

SecondaryPharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib

Maximum plasma concentration on Day -3 and Day 28 of Cycle 1.

Time frame:: Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hours (hr) postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days)
Reported as:: Geometric mean · nanogram per milliliter (ng/mL)

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib
nanogram per milliliter (ng/mL)	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Cycle 1 Day -3	127 ± 51	167 ± 40	214 ± 87
Cycle 1 Day 28	NA ± NA	NA ± NA	298 ± 64

SecondaryPharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of Abemaciclib

AUC on Day -3 and Day 28 of Cycle 1 are AUC from time zero to infinity \[AUC(0-∞)\] and AUC during one dosing interval at steady state (AUCτ,ss), respectively.

Time frame:: Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hr postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days)
Reported as:: Geometric mean · Nanogram*hour/Millilitre (ng*hr/mL)

Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of Abemaciclib
Nanogramhour/Millilitre (nghr/mL)	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
AUC(0-∞)	NA ± NA	4450 ± 39	5480 ± 95
AUCτ,ss (n=2,2,5)	NA ± NA	NA ± NA	3020 ± 73

SecondaryPercentage of Participants With a Tumor Response: Objective Response Rate (ORR)

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions.

Time frame:: Baseline to Measured Progressive Disease (Up To 24 months)
Reported as:: Number · percentage of participants

Percentage of Participants With a Tumor Response: Objective Response Rate (ORR)
percentage of participants	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Percentage of Participants With a Tumor Response: Objective Response Rate (ORR)	0	0	0

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 - 100 mg Abemaciclib	—	0/3 (0%)	3/3 (100%)
Cohort 2 - 150 mg Abemaciclib	—	2/3 (66.7%)	3/3 (100%)
Cohort 3 - 200 mg Abemaciclib	—	2/6 (33.3%)	6/6 (100%)

Most frequent serious events

Most frequent serious events
Event	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Gastric fistulaGastrointestinal disorders	0/3	1/3	0/6
Biliary tract infectionInfections and infestations	0/3	1/3	0/6
Lung infectionInfections and infestations	0/3	1/3	0/6
Decreased appetiteMetabolism and nutrition disorders	0/3	0/3	1/6
Cancer painNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/3	0/3	1/6
Deep vein thrombosisVascular disorders	0/3	0/3	1/6

Most frequent other events

Showing 10 of 65

Most frequent other events
Event	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
DiarrhoeaGastrointestinal disorders	1/3	2/3	6/6
Blood creatinine increasedInvestigations	2/3	2/3	5/6
LeukopeniaBlood and lymphatic system disorders	2/3	0/3	1/6
NeutropeniaBlood and lymphatic system disorders	2/3	1/3	2/6
ThrombocytopeniaBlood and lymphatic system disorders	2/3	1/3	0/6
VomitingGastrointestinal disorders	1/3	0/3	4/6
Aspartate aminotransferase increasedInvestigations	0/3	2/3	1/6
White blood cell count decreasedInvestigations	0/3	1/3	4/6
Decreased appetiteMetabolism and nutrition disorders	2/3	1/3	3/6
NauseaGastrointestinal disorders	1/3	0/3	3/6

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib	Total
Mean	61.3 ± 11.06	63.0 ± 1.00	56.0 ± 11.70	59.1 ± 9.77

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib	Total
Female	1	1	5	7
Male	2	2	1	5

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib	Total
American Indian or Alaska Native	0	0	0	0
Asian	3	3	6	12
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	0	0	0	0
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib	Total
Japan	3	3	6	12

Study locations

1 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.
Tokyo, 104-0045, Japan

References and documents

Publications

Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13. PubMed 24919854 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02014129
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Dec 18, 2013
Start date: Dec 18, 2013
Primary completion: Apr 1, 2015
Completion: Aug 21, 2019
Results posted: Aug 24, 2020
Last update: Aug 24, 2020

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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