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Advanced CancerPhase 1NCT02919696

A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers

A Phase 1 study testing Abemaciclib in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 3 sites in China.

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 purpose of this study is to determine the safety of the study drug known as abemaciclib in native Chinese participants with advanced and/or metastatic cancers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Metastatic Cancer
What is being tested?
Abemaciclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
3 sitesChina
Study dates
7 Aug 2017to 3 Sep 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant must have histological or cytological evidence of cancer which is advanced and/or metastatic, and is an appropriate candidate for experimental therapy in the judgment of the investigator, after available standard therapies have ceased to provide clinical benefit.
  • Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Are native Chinese men or women.
  • Have adequate organ function, including:
  • Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 109/Liters (L), platelets ≥100 x 109/L, and hemoglobin ≥9 grams per deciliter. Participants may receive erythrocyte transfusions to achieve this hemoglobin level or platelet transfusions to achieve platelet levels at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after transfusion.
  • Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3.0 times ULN.
Show all 10Show fewer
  • Renal: Serum creatinine ≤1.2 milligrams per deciliter (mg/dL) for males or ≤1.0 mg/dL for females.
  • Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Recovered from the acute effects of therapy (treatment- related toxicity resolved to baseline) except for residual alopecia.
  • Have an estimated life expectancy of ≥12 weeks.

Who cannot join

  • Have received previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) within 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.
  • Have an acute leukemia or other relevant cancers at the discretion of the investigator.
  • Females who are pregnant or lactating.
  • Participants consuming drugs or foods that are known to be inducers (for example, grapefruit juice, phenytoin, carbamazepine) or strong inhibitors of CYP3A4 should be excluded during Cycle 1.
  • Have history or evidence of central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic participants without history of CNS metastases is not required for enrollment.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • 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.

    Changsha, 410013

  • 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.

    Shanghai, 200030

  • 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.

    Shanghai

Other trials in China

About this study

Official title: A Phase 1 Study of Abemaciclib in Native Chinese Patients With Advanced and/or Metastatic Cancers

The purpose of this study is to determine the safety of the study drug known as abemaciclib in native Chinese participants with advanced and/or metastatic cancers.

Being tested
Abemaciclib
Keywords
CDK4/6 Inhibitor
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally

Study groups in NCT02919696
Study groupRoleWhat they receive
Abemaciclib Dose Level 1ExperimentalAbemaciclib 150 milligram (mg) administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable pharmacokinetic (PK) sampling following a single dose and repeated doses.
Receives: Drug: Abemaciclib
Abemaciclib Dose Level 2ExperimentalAbemaciclib 200 mg administered every 12 hours, orally, cycle 1 and then in cycle 2. Participants may continue to receive treatment until discontinuation criteria are met. One cycle is defined as 28 days. (Cycle 1: 32 days), with modifications during Cycle 1 to enable PK sampling following a single dose and repeated doses.
Receives: Drug: Abemaciclib

What is being measured

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

  1. Number of Participants With One or More Drug Related Adverse Events

    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.

    Measured: Baseline through End of Study (Up to 10 Months)

Secondary outcomes (6)

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites Single Dose

    Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and its Metabolites following a single oral dose.

    Measured: Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose

  2. PK: Maximum Concentration (Cmax) of Abemaciclib and Its Metabolites (Twice Daily Dosing)

    PK: Maximum Concentration (Cmax) of Abemaciclib and its Metabolites following a twice daily dosing.

    Measured: Cycle 1, Day(D) 31; Predose, 1, 2, 4, 6, 8, 10, 24 Hours Postdose

  3. PK: Area Under Concentration Time Curve (AUC) From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites Single Dose

    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.

    Measured: Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose

  4. PK: AUC From Time Zero to 12 Hours (AUC [0-12]) of Abemaciclib and Its Metabolites (Twice Daily Dosing)

    PK: AUC from Time Zero to 12 hours (AUC [0-12]) of Abemaciclib and its Metabolites following twice daily dosing

    Measured: Cycle 1, Day(D) 31; Predose, 1, 2, 4, 6, 8, 10, 24 Hours Postdose

  5. PK: AUC From Time Zero to Infinity (AUC[0-inf]) of Abemaciclib and Its Metabolites Single Dose

    PK: AUC from Time Zero to Infinity (AUC[0-inf]) of Abemaciclib and its Metabolites following a single oral dose.

    Measured: Cycle 1, Day(D)1; Predose, 1, 4, 6, 8, 10, 24, 48 Hours Postdose

  6. Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

    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.

    Measured: Baseline to Measured Progressive Disease (Up to 13 Months )

Timeline

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

  1. First posted29 Sep 2016 (estimated)
  2. Study start7 Aug 2017
  3. Primary completion23 Nov 2018
  4. Study completion3 Sep 2019

Resources

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02919696
Sponsor's protocol ID
15531
Other IDs
I3Y-CR-JPBR
Status last verified
1 Dec 2019
First submitted
28 Sep 2016
Last updated
25 Sep 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang J, Yang N, Ji D, Shen W, Li W, Han R, Wang N, Tao H, Chapman SC, Sykes AK, Zhang W, Hu X. A Randomized Phase I Study of Abemaciclib in Chinese Patients with Advanced and/or Metastatic Cancers. Target Oncol. 2021 Mar;16(2):177-187. doi: 10.1007/s11523-020-00789-9. Epub 2021 Jan 25.

    PubMed 33492568

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abemaciclib in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 3 sites in China.

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 5 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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 25 Sep 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 One or More Drug Related Adverse Events (time frame: Baseline through End of Study (Up to 10 Months)). 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 NCT02919696, 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 25 Sep 2020.

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