GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

Sponsor
Reema A. Patel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05391126
Collaborator
(none)
178
2
32

Study Details

Study Description

Brief Summary

This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (*1/*28) (heterozygotes) and usual UGT metabolizers (*1/*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (*1/*28, *1/*1) will be randomized to genotype-guided dosing versus usual care.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
178 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Genocare Guided

Drug: Irinotecan
Usual dosing per package insert.
Other Names:
  • Nano-liposomal Irinotecan
  • Onyvide
  • No Intervention: Usual Care

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events Frequency [6 months]

      To compare the frequency of cycle 1 grade 3-5 adverse effects in individuals with a *1/*28 or *1/*1 genotype who receive genotype-guided dosing and to those who are randomized to receive usual care.

    Secondary Outcome Measures

    1. Overall Survival [5 years]

      To evaluate overall survival between individuals randomized to receive genotype-guided dosing and those who are randomized to receive usual care.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.

    • Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.

    • Age ≥ 18 years.

    • ECOG performance status ≤ 1.

    • Patients must have adequate organ and marrow function as defined below:

    • Measurable or non-measurable disease.

    Exclusion Criteria:
    • Patients who received prior treatment with irinotecan are excluded.

    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.

    • Pregnant women are excluded from this study.

    • Patients who are not planned for treatment of their cancer.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Reema A. Patel

    Investigators

    • Principal Investigator: Reema A Patel, MD, University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reema A. Patel, Assistant Professor, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT05391126
    Other Study ID Numbers:
    • 78068
    First Posted:
    May 25, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022