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Trial record 2 of 5 for:    KRAS G12C

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165031
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : February 5, 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 : December 3, 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


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
Hide Hide 26 study locations
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United States, California
Beverly Hills Cancer Center Not yet recruiting
Beverly Hills, California, United States, 90211
Contact    310-432-8952      
Principal Investigator: David Berz         
Univ of California Irvine College of Medicine Not yet recruiting
Orange, California, United States, 92868
Contact    7144566550      
Principal Investigator: Sai-Hong Ignatius Ou         
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94158
Contact    415-353-7070      
Principal Investigator: Pamela Munster         
United States, Illinois
University of Chicago Medicine-Comprehensive Cancer Center Not yet recruiting
Chicago, Illinois, United States, 60637
Contact    773-702-4627      
Principal Investigator: Christine Bestvina         
United States, Indiana
Indiana Univ Melvin & Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact    317-278-0067      
Principal Investigator: Gregory Durm         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact    6177262515      
Principal Investigator: Rebecca Suk Heist         
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact    617-632-5869      
Principal Investigator: Geoffrey I Shapiro         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact    603-650-6344      
Principal Investigator: Konstantin Dragnev         
United States, New Jersey
Memorial Sloan Kettering Cancer Center Not yet recruiting
Middletown, New Jersey, United States, 07748
Contact    646-888-4201      
Principal Investigator: Bob Li         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
Harrison, New York, United States, 10604
Contact    914-367-7015      
Principal Investigator: Bob Li         
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact    646-888-4201      
Principal Investigator: Bob Li         
United States, North Carolina
Duke University Medical Center Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact    919-668-6688      
Principal Investigator: Thomas E Stinchcombe         
United States, Oklahoma
University of Oklahoma Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact    405-271-1112      
Principal Investigator: Raid Maki Dawood Aljumaily         
United States, Tennessee
Sarah Cannon Research Institute SCRI Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact    615-329-7274      
Principal Investigator: SMO Sarah Cannon Research Inst.         
United States, Texas
University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact    713-745-6754      
Principal Investigator: Ferdinandos Skoulidis         
United States, Washington
Seattle Cancer Care Alliance Not yet recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Gabriela Chiorean         
Australia, New South Wales
St Vincent's Hospital Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact    61293555611      
Principal Investigator: Rasha Cosman         
Australia, Western Australia
Linear Clinical Research Ltd Recruiting
Nedlands, Western Australia, Australia, 6009
Contact    61861510923      
Principal Investigator: Michael Millward         
Canada, Alberta
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact    7804328248      
Principal Investigator: Quincy Chu         
Canada, Ontario
Princess Margaret Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact    4169463550      
Principal Investigator: Adrian Sacher         
Italy
IRCCS Ospedale San Raffaele Not yet recruiting
Milano, Italy, 20132
Contact    390291751541      
Principal Investigator: Stefano Cascinu         
Japan
National Cancer Center Hospital East Not yet recruiting
Kashiwa, Chiba, Japan, 277 8577
Contact    81120023812      
Principal Investigator: Yasutoshi Kuboki         
Shizuoka Cancer Center Not yet recruiting
Sunto-Gun, Shizuoka, Japan, 411-8777
Contact    81120023812      
Principal Investigator: Kazushige Wakuda         
National Cancer Center Hospital Not yet recruiting
Chuo-Ku, Tokyo, Japan, 104-0045
Contact    81120023812      
Principal Investigator: Toshio Shimizu         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact    0034932746000      
Principal Investigator: Elena Garralda Cabanas         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact    0034913908626      
Principal Investigator: Luis Paz-Ares Rodríguez         
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: February 5, 2020
Last Verified: February 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
Cetuximab
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors