Neoplasm MetastasisPhase 1NCT02014129

A Study of LY2835219 in Japanese Participants With Advanced Cancer

A Phase 1 study testing LY2835219 in people with Neoplasm Metastasis and Lymphoma, run by Eli Lilly and Company at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 20 years and older
Conditions the study is for: Neoplasm Metastasis, Lymphoma
What is being tested?: LY2835219
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteJapan
Study dates: 18 Dec 2013to 21 Aug 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Japan1 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

Other trials in Japan

About this study

Official title: A Phase 1 Study of LY2835219 in Japanese Patients With Advanced Cancer

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

Conditions: Neoplasm Metastasis, Lymphoma
Being tested: LY2835219
Medical subject headings: Neoplasm Metastasis, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2835219Drug
Also called abemaciclib
Administered orally

Study groups in NCT02014129
Study group	Role	What they receive
Cohort 1 - 100 mg Abemaciclib	Experimental	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. Receives: Drug: LY2835219
Cohort 2 - 150 mg Abemaciclib	Experimental	150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. Receives: Drug: LY2835219
Cohort 3 - 200 mg Abemaciclib	Experimental	200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. Receives: Drug: LY2835219

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Cycle 1 = 32 days

Secondary outcomes (3)

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib
Maximum plasma concentration on Day -3 and Day 28 of Cycle 1.
Measured: 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.
Measured: 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.
Measured: Baseline to Measured Progressive Disease (Up To 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201321 Aug 2019

First posted18 Dec 2013 (estimated)
Study start18 Dec 2013
Primary completion1 Apr 2015
Study completion21 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02014129
Sponsor's protocol ID: 15154
Other IDs: I3Y-JE-JPBC
Status last verified: 15 Sep 2019
First submitted: 12 Dec 2013
Last updated: 24 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of LY2835219 in Japanese Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT02014129
Acronym / sponsor ID: 15154
Conditions: Neoplasm Metastasis, Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 18 Dec 2013 (actual)
Primary completion: 1 Apr 2015 (actual)
Study completion: 21 Aug 2019 (actual)
First posted: 18 Dec 2013 (estimated)
Results: Posted 24 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1 - 100 mg Abemaciclib	Experimental	Drug: LY2835219100 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.
Cohort 2 - 150 mg Abemaciclib	Experimental	Drug: LY2835219150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Cohort 3 - 200 mg Abemaciclib	Experimental	Drug: LY2835219200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2835219Also: abemaciclibAdministered orally	Drug	Cohort 1 - 100 mg Abemaciclib, Cohort 2 - 150 mg Abemaciclib, Cohort 3 - 200 mg Abemaciclib

Primary outcome

Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT)
Time frame: Cycle 1 = 32 days
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.

3 secondary outcomes

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib
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
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)
Time frame: Baseline to Measured Progressive Disease (Up To 24 months)

Results and safety

Results posted to the registry on 24 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 - 100 mg Abemaciclib	3	3
Cohort 2 - 150 mg Abemaciclib	3	3
Cohort 3 - 200 mg Abemaciclib	6	6

Primary outcome: Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT)

Time frame: Cycle 1 = 32 days. Count of participants. Unit: Participants

Measure	Cohort 1 - 100 mg Abemaciclib n = 3	Cohort 2 - 150 mg Abemaciclib n = 3	Cohort 3 - 200 mg Abemaciclib n = 6
Value	0	0	1

Population analysed: All participants who received at least one dose of study drug and took at least 75% of planned dose in Cycle 1 or experienced a DLT in Cycle 1.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - 100 mg Abemaciclib	0 of 3 (0%)	3 of 3 (100%)	Not reported
Cohort 2 - 150 mg Abemaciclib	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Cohort 3 - 200 mg Abemaciclib	2 of 6 (33.3%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24919854Gelbert 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2835219 in people with Neoplasm Metastasis and Lymphoma, run by Eli Lilly and Company at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT) (time frame: Cycle 1 = 32 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02014129, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.