ClinicalTrials.Veeva

Menu

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

R

Reema A. Patel

Status

Enrolling

Conditions

Pancreatic Cancer
Colorectal Cancer

Treatments

Drug: Irinotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT05391126
MCC-22-GI-125-PMC

Details and patient eligibility

About

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.

Enrollment

178 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

178 participants in 2 patient groups

Genocare Guided
Experimental group
Treatment:
Drug: Irinotecan
Usual Care
No Intervention group

Trial contacts and locations

1

Loading...

Central trial contact

Reema A Patel, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems