Recruiting

Genotype-Guided Dosing

Sponsor:

Reema A. Patel

Code:

NCT05391126

Conditions

Colorectal Cancer

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Irinotecan

Study Details

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.

Conditions

Colorectal Cancer

Pancreatic Cancer

Study ID

NCT05391126

Start date

Sep 28, 2022

Status verified date

Dec, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Genocare Guided

no intervention: Usual Care

Interventions

Irinotecan

Usual dosing per package insert.

Primary outcome measure

  • Adverse Events Frequency [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Reema A Patel, MD

8592186650reema.patel@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Yvonne Taul

859-323-2354Yvonne.Taul@uky.edu

More Information

Sponsor

Reema A. Patel

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reema A. Patel on 2025-12-16.