A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Eli Lilly and Company
Study ID
NCT04165031
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY3499446 — DRUG
    Administered orally
  • Abemaciclib — DRUG
    Administered orally
  • Cetuximab — DRUG
    Administered IV
  • Erlotinib — DRUG
    Administered orally
  • Docetaxel — DRUG
    Administered IV

Study Details

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.

Key Dates

Start date
Nov 28, 2019
Status verified
Oct 2021
Primary completion
Oct 30, 2020
Completion
Oct 30, 2020

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 Day Cycle) ]

Locations (4)

FacilityCityStateZIP
Indiana Univ Melvin & Bren Simon Cancer CenterIndianapolisIndiana46202
Memorial Sloan Kettering Cancer CenterMiddletownNew Jersey07748
Memorial Sloan Kettering Cancer CenterHarrisonNew York10604
Memorial Sloan Kettering Cancer CenterNew YorkNew York10022

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Indiana Univ Melvin & Bren Simon Cancer Center· Indianapolis, INMemorial Sloan Kettering Cancer Center· Middletown, NJMemorial Sloan Kettering Cancer Center· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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