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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04165031
Registration number
NCT04165031
Ethics application status
Date submitted
14/11/2019
Date registered
15/11/2019
Date last updated
24/11/2021
Titles & IDs
Public title
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
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Scientific title
A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation
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Secondary ID [1]
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J2K-MC-JZKA
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Secondary ID [2]
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17501
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Non-Small Cell Lung Cancer
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Colorectal Cancer
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY3499446
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Cetuximab
Treatment: Drugs - Erlotinib
Treatment: Drugs - Docetaxel
Experimental: LY3499446 Phase 1 Cohort A1 High Dose - Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
Experimental: LY3499446 Phase 1 Cohort AO Mid Dose - Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
Experimental: LY3499446 Phase 1 Cohort A-2 Low Dose - Participants received low dose LY3499446 as oral monotherapy once daily (QD) in 21-Day cycles.
Experimental: LY3499446 + Combination Drugs Phase 1 - LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).
This trial was terminated prior to initiation of combination therapy cohorts.
Experimental: LY3499446 Monotherapy + Combination Drugs Phase 2 - LY3499446 as oral monotherapy and LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).
The trial was terminated prior to initiation of Phase 2 of this study.
Active Comparator: Docetaxel Phase 2 - Docetaxel IV infusion.
The trial was terminated prior to initiation of Phase 2 of this study.
Treatment: Drugs: LY3499446
Administered orally
Treatment: Drugs: Abemaciclib
Administered orally
Treatment: Drugs: Cetuximab
Administered IV
Treatment: Drugs: Erlotinib
Administered orally
Treatment: Drugs: Docetaxel
Administered IV
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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DLT is defined as an event that is clinically significant and not clearly related to disease progression or intercurrent illness that occurred within the DLT observation period of the Cycle 1 timeframe.
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Timepoint [1]
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Cycle 1 (21 Day Cycle)
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Primary outcome [2]
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Phase 2: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) in Colorectal Cancer (CRC) Cohorts and Other Tumors Cohort
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Assessment method [2]
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ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
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Timepoint [2]
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Baseline through Measured Progressive Disease
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Primary outcome [3]
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Phase 2: Progression-Free Survival (PFS) Non-Small Lung Cancer (NSCLC Cohorts)
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Assessment method [3]
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PFS was defined as the time from study enrollment (for non-randomized cohorts)/ the time from randomization (for randomized cohorts) to the first observation of progressive disease (PD) or death without documented disease progression per RECIST V1.1 criteria.
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Timepoint [3]
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Baseline to Objective Progression or Death Due to Any Cause
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Secondary outcome [1]
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Phase 1: Pharmacokinetics (PK): Average Concentration of LY3499446
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Assessment method [1]
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Average concentration after the first dose of LY3499446.
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Timepoint [1]
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Cycle 1 Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 8, 24 hours post-dose
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Secondary outcome [2]
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Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Abemaciclib
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Assessment method [2]
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PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib
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Timepoint [2]
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Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
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Secondary outcome [3]
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Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Cetuximab
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Assessment method [3]
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PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab
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Timepoint [3]
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Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
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Secondary outcome [4]
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Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Erlotinib
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Assessment method [4]
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PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib
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Timepoint [4]
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Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
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Secondary outcome [5]
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Phase 1: ORR: Percentage of Participants Who Achieve CR or PR
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Assessment method [5]
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ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
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Timepoint [5]
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Baseline through Measured Progressive Disease (Up to 11 Months)
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Secondary outcome [6]
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Phase 1: PFS
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Assessment method [6]
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PFS was defined as the time from study enrollment (for non-randomized cohorts)/ the time from randomization (for randomized cohorts) to the first observation of progressive disease (PD) overall response or death without documented disease progression per RECIST V1.1 criteria.
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Timepoint [6]
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Baseline to Objective Progression or Death Due to Any Cause (Up to 11 Months)
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Secondary outcome [7]
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Phase 1: Duration of Response (DoR)
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Assessment method [7]
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DoR was defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST v1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
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Timepoint [7]
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Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months)
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Secondary outcome [8]
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Phase 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
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Assessment method [8]
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DCR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed CR, confirmed PR, or SD out of all participants treatment. Best response is determined from a sequence of responses assessed. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
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Timepoint [8]
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Baseline through Measured Progressive Disease (Up to 11 Months)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/10/2020
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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St Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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Linear Clinical Research Ltd - Nedlands
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Indiana
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Country [2]
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United States of America
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State/province [2]
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New Jersey
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Country [3]
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United States of America
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State/province [3]
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New York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04165031
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04165031
Download to PDF