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A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

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: NCT01394016
Recruitment Status : Active, not recruiting
First Posted : July 14, 2011
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 12, 2011
First Posted Date  ICMJE July 14, 2011
Last Update Posted Date October 5, 2021
Actual Study Start Date  ICMJE December 7, 2009
Actual Primary Completion Date May 29, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
Number of participants with clinically significant effects (physical assessments and safety lab tests) [ Time Frame: Baseline through study completion (approximately 38 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
  • Number of participants with tumor response [ Time Frame: 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 ]
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
  • Number of participants with tumor response [ Time Frame: Baseline through study completion (approximately 38 months) ]
  • Pharmacokinetics, maximum plasma concentration (Cmax) [ Time Frame: Days -3, -2, 1, Baseline, Days 1, 15, 28, and 29 of Cycle 1 ]
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: Days -3, -2, 1, Baseline, Days 1, 15, 28, and 29 of Cycle 1 ]
  • Recommended dose for phase 2 studies [ Time Frame: Baseline to study completion (approximately 38 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of LY2835219 In Participants With Advanced Cancer
Official Title  ICMJE A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Participants With Advanced Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • 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 Name: abemaciclib
  • Drug: Fulvestrant
    Fulvestrant is administered intramuscularly into the buttocks as specified in the label in Part G only.
Study Arms  ICMJE Experimental: LY2835219
Interventions:
  • Drug: LY2835219
  • Drug: Fulvestrant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2013)
220
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2011)
100
Estimated Study Completion Date  ICMJE December 5, 2022
Actual Primary Completion Date May 29, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01394016
Other Study ID Numbers  ICMJE 13199
I3Y-MC-JPBA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date October 1, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP