A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
NCT ID: NCT04165031
Last Updated: 2021-11-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2019-11-28
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LY3499446 Phase 1 Cohort A1 High Dose
Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
LY3499446
Administered orally
LY3499446 Phase 1 Cohort AO Mid Dose
Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
LY3499446
Administered orally
LY3499446 Phase 1 Cohort A-2 Low Dose
Participants received low dose LY3499446 as oral monotherapy once daily (QD) in 21-Day cycles.
LY3499446
Administered orally
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.
LY3499446
Administered orally
Abemaciclib
Administered orally
Cetuximab
Administered IV
Erlotinib
Administered orally
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.
LY3499446
Administered orally
Abemaciclib
Administered orally
Cetuximab
Administered IV
Erlotinib
Administered orally
Docetaxel Phase 2
Docetaxel IV infusion.
The trial was terminated prior to initiation of Phase 2 of this study.
Docetaxel
Administered IV
Interventions
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LY3499446
Administered orally
Abemaciclib
Administered orally
Cetuximab
Administered IV
Erlotinib
Administered orally
Docetaxel
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Indiana Univ Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
Memorial Sloan Kettering Cancer Center
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
Other Identifiers
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J2K-MC-JZKA
Identifier Type: OTHER
Identifier Source: secondary_id
2019-003070-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17501
Identifier Type: -
Identifier Source: org_study_id