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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919696
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Drug: Abemaciclib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Abemaciclib in Native Chinese Patients With Advanced and/or Metastatic Cancers
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abemaciclib

Arm Intervention/treatment
Experimental: Abemaciclib Dose Level 1

Cycle 1: Abemaciclib administered orally.

Cycle 2: Abemaciclib administered orally.

Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Experimental: Abemaciclib Dose Level 2

Cycle 1: Abemaciclib administered orally.

Cycle 2: Abemaciclib administered orally.

Drug: Abemaciclib
Administered orally
Other Name: LY2835219




Primary Outcome Measures :
  1. Number of Participants with One or More Drug Related Adverse Events [ Time Frame: Baseline through End of Study (Approximately 13 Months) ]
    Number of participants with one or more drug related adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib and its Metabolites [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 32 ]
    PK: Cmax of abemaciclib and its metabolites

  2. PK: Area Under the Concentration Time Curve (AUC) from Time Zero to Infinity (AUC[0-inf]) of Abemaciclib and its Metabolites [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 32 ]
    PK: AUC[0-inf] of abemaciclib and its metabolites

  3. PK: AUC from Time Zero to Time t, Where t is the Last Time Point with a Measurable Concentration (AUC [0-tlast]) of Abemaciclib and its Metabolites [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 32 ]
    PK: AUC [0-tlast] of abemaciclib and its metabolites

  4. Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Measured Progressive Disease (Approximately 13 Months ) ]
    ORR: Percentage of participants with a CR or PR



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
    • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919696


Locations
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China
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, China, 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, China, 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, China
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02919696    
Other Study ID Numbers: 15531
I3Y-CR-JPBR ( Other Identifier: Eli Lilly and Company )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 1, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
CDK4/6 Inhibitor
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms
Neoplastic Processes
Pathologic Processes