A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

February 27, 2023 updated by: Eli Lilly and Company

A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Participants With Advanced Cancer

The purpose of this study is to determine a safe dose of LY2835219 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2835219 in this population. Efficacy measures will be used to assess the activity of LY2835219 in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • 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.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • 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
    • Texas
      • San Antonio, Texas, United States, 78229
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For all Parts (Dose escalation and expansion): The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy either after available standard therapies have ceased to provide clinical benefit (Parts A, B, C, D, E and F) or in combination with fulvestrant (Part G only)
  • For Dose Escalation (Part A): The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced and/or metastatic

  • For Dose Expansion (Parts B, C, D, E, F and G): The participant must have histological or cytological evidence of one of the following cancers:

    • Part B: Non-small cell lung cancer of any subtype that is advanced and/or metastatic
    • Part C: Glioblastoma multiforme that has progressed or recurred after radiotherapy and/or chemotherapy
    • Part D: Breast cancer that is advanced and/or metastatic
    • Part E: Melanoma that is advanced and/or metastatic
    • Part F: Colorectal Cancer
    • Part G: Breast Cancer that is not only advanced and/or metastatic but also hormone receptor positive

  • As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma

    • For Parts A and G: Have measurable or nonmeasurable disease
    • For Parts B, C, D, E and F: Have measurable disease
  • Have given written informed consent prior to any study-specific procedures
  • Have adequate hematologic, hepatic, and renal function
  • Have a performance status less than or equal to 1 for Dose Escalation (Part A) and less than or equal to 2 for Dose Confirmation (Parts B, C, D, E, F and G) on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) with the exception of fulvestrant (for Part G only) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
  • Females with child bearing potential must have a negative serum pregnancy test within 3 days of the first dose of study drug
  • Have an estimated life expectancy of greater than or equal to 12 weeks
  • Are able to swallow capsules

Exclusion Criteria:

  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
  • Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), sudden cardiac death or sudden cardiac arrest
  • 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)
  • For Dose Escalation (Part A): Have central nervous system (CNS) malignancy or metastasis
  • For Dose Confirmation (Parts B, D, E, F and G): Have CNS metastasis that is radiographically or clinically unstable less than 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids
  • For Dose Confirmation (Part C): Have glioblastoma multiforme that is radiographically or clinically unstable less than 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids
  • Have an acute leukemia
  • Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug
  • Females who are pregnant or lactating
  • Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies) Screening is not required for enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY2835219
Drug: LY2835219
Administered orally, daily for 28-day cycles for two planned cycles. For Part G only in addition to LY2835219 as above, fulvestrant is administered as specified in the label. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Other Names:
  • abemaciclib
Drug: Fulvestrant
Fulvestrant is administered intramuscularly into the buttocks as specified in the label in Part G only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with clinically significant effects (physical assessments and safety lab tests)
Time Frame: Baseline through study completion (approximately 38 months)
Baseline through study completion (approximately 38 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with tumor response
Time Frame: Baseline through study completion (approximately 38 months)
Baseline through study completion (approximately 38 months)
Pharmacokinetics, maximum plasma concentration (Cmax)
Time Frame: Days -3, -2, -1, Days 1, 15, 22, 28 and 29 of Cycle 1
Days -3, -2, -1, Days 1, 15, 22, 28 and 29 of Cycle 1
Pharmacokinetics, area under the curve (AUC)
Time Frame: Days -3, -2, -1, Days 1, 15, 22, 28 and 29 of Cycle 1
Days -3, -2, -1, Days 1, 15, 22, 28 and 29 of Cycle 1
Recommended dose for phase 2 studies
Time Frame: Baseline to study completion (approximately 38 months)
Baseline to study completion (approximately 38 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2009

Primary Completion (Actual)

May 29, 2014

Study Completion (Actual)

April 12, 2022

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13199
  • I3Y-MC-JPBA (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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