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Trial record 1 of 1 for:    LY3499446
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A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

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: NCT04165031
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : November 15, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Non-Small Cell Lung Cancer Colorectal Cancer Drug: LY3499446 Drug: Abemaciclib Drug: Cetuximab Drug: Erlotinib Drug: Docetaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation
Actual Study Start Date : November 28, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3499446 Phase 1
Participants given LY3499446 monotherapy orally.
Drug: LY3499446
Administered orally

Experimental: LY3499446 + Abemaciclib Phase 1
Participants given LY3499446 and abemaciclib orally.
Drug: LY3499446
Administered orally

Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Experimental: LY3499446 + Cetuximab Phase 1
Participants given LY3499446 orally and cetuximab intravenously (IV).
Drug: LY3499446
Administered orally

Drug: Cetuximab
Administered IV

Experimental: LY3499446 + Erlotinib Phase 1
Participants given LY3499446 and erlotinib orally.
Drug: LY3499446
Administered orally

Drug: Erlotinib
Administered orally

Experimental: LY3499446 Phase 2
Participants given LY3499446 monotherapy orally.
Drug: LY3499446
Administered orally

Experimental: LY3499446 + Abemaciclib Phase 2
Participants given LY3499446 and abemaciclib orally.
Drug: LY3499446
Administered orally

Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Experimental: LY3499446 + Erlotinib Phase 2
Participants given LY3499446 and erlotinib orally.
Drug: LY3499446
Administered orally

Drug: Erlotinib
Administered orally

Experimental: LY3499446 + Cetuximab Phase 2
Participants given LY3499446 orally and cetuximab IV.
Drug: LY3499446
Administered orally

Drug: Cetuximab
Administered IV

Active Comparator: Docetaxel Phase 2
Participants given docetaxel IV.
Drug: Docetaxel
Administered IV




Primary Outcome Measures :
  1. Phase 1: Number or Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 Day Cycle) ]
    Phase 1: Number or Participants with DLTs

  2. Phase 2: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) (CRC Cohorts and Other Tumors Cohort) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 24 Months) ]
    Phase 2: ORR: Percentage of Participants Who Achieve CR or PR (CRC Cohorts and Other Tumors Cohort)

  3. Phase 2: Progression-Free Survival (PFS) (NSCLC Cohorts) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months) ]
    Phase 2: PFS (NSCLC Cohorts)


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Average Concentration at Steady State of LY3499446 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles) ]
    PK: Average Concentration at Steady State of LY3499446

  2. PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib [ Time Frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles) ]
    PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib

  3. PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab [ Time Frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles) ]
    PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab

  4. PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib [ Time Frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles) ]
    PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib

  5. Phase 1: ORR: Percentage of Participants Who Achieve CR or PR [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 24 Months) ]
    Phase 1: ORR: Percentage of Participants Who Achieve CR or PR

  6. Phase 1: PFS [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months) ]
    Phase 1: PFS

  7. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 24 Months) ]
    DoR

  8. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 24 Months) ]
    Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD



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:

  • Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body
  • For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health
  • Participants must be willing to use highly effective birth control
  • Participants must have adequate organ function
  • Participants must be able to swallow capsules

Exclusion Criteria:

  • Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled
  • Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
  • Participants must not have cancer of the central nervous system that is not stable
  • Participants must not be pregnant or breastfeeding
  • Participants must not use herbal supplements

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): NCT04165031


Locations
Show Show 26 study locations
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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04165031    
Other Study ID Numbers: 17501
J2K-MC-JZKA ( Other Identifier: Eli Lilly and Company )
2019-003070-53 ( EudraCT Number )
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Docetaxel
Erlotinib Hydrochloride
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological