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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04165031




Registration number
NCT04165031
Ethics application status
Date submitted
14/11/2019
Date registered
15/11/2019

Titles & IDs
Public title
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
Scientific title
A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation
Secondary ID [1] 0 0
J2K-MC-JZKA
Secondary ID [2] 0 0
17501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Non-Small Cell Lung Cancer 0 0
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Cycle 1 (21 Day Cycle)
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline through Measured Progressive Disease
Primary outcome [3] 0 0
Phase 2: Progression-Free Survival (PFS) Non-Small Lung Cancer (NSCLC Cohorts)
Timepoint [3] 0 0
Baseline to Objective Progression or Death Due to Any Cause
Secondary outcome [1] 0 0
Phase 1: Pharmacokinetics (PK): Average Concentration of LY3499446
Timepoint [1] 0 0
Cycle 1 Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 8, 24 hours post-dose
Secondary outcome [2] 0 0
Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Abemaciclib
Timepoint [2] 0 0
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Secondary outcome [3] 0 0
Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Cetuximab
Timepoint [3] 0 0
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Secondary outcome [4] 0 0
Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Erlotinib
Timepoint [4] 0 0
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Secondary outcome [5] 0 0
Phase 1: ORR: Percentage of Participants Who Achieve CR or PR
Timepoint [5] 0 0
Baseline through Measured Progressive Disease (Up to 11 Months)
Secondary outcome [6] 0 0
Phase 1: PFS
Timepoint [6] 0 0
Baseline to Objective Progression or Death Due to Any Cause (Up to 11 Months)
Secondary outcome [7] 0 0
Phase 1: Duration of Response (DoR)
Timepoint [7] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months)
Secondary outcome [8] 0 0
Phase 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
Timepoint [8] 0 0
Baseline through Measured Progressive Disease (Up to 11 Months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2020
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04165031